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:?:eport and
Recommendations
Research
Involving
risoners
^he NaT:ional Commission
for the Protectign of
Human Subjects
r of Biomedical and
Behavioral Research
1976
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Report and
Recommendations
Research
Involving
Prisoners
The National Commission
for the Protection of
Human Subjects
of Biomedical and
Behavioral Research
1976
DHEW Publication No. (OS) 76-131
7?
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/f76
National Commission for the Protection of Human Subjects
of Biomedical and Behavioral Research
Westwood Building, Room 125
5333 Westbard. Avenue
Bethesda, Maryland 20016
October 1, 1976
The President
The White House
Washington, D.C. 20500
Dear Mr. President:
On behalf of the National Commission for the Protection
of Human Subjects of Biomedical and Behavioral Research,
I am pleased to transmit our Report and Recommendations ;
Research Involving Prisoners . Under Public Law 93-348,
the Commission is charged to submit periodic reports to the
President, the Congress and the Secretary of Health, Educa-
tion, and Welfare on various aspects of research involving
human subjects, including the participation of prisoners in
biomedical and behavioral research.
The Commission's deliberations and recommendations to
the Congress and the Secretary, on research involving pris-
oners, as well as a summary of background materials, are
included in this volume. An appendix volume, containing
materials reviewed by the Commission in its deliberations,
will accompany the report.
The Commission has conducted extensive public delibera-
tions on the issues surrounding the involvement of prisoners
in research. These deliberations are reflected in our recom-
mendations, which we hope will provide a useful resolution
of this matter of public concern. We are grateful for the
opportunity to prepare the report.
i'espectfully
Kenneth JV_jrya!ii, M.D.
Chairman
National Commission for the Protection of Human Subjects
of Biomedical and Behavioral Research
Westwood Building, Room 125
5333 Westbord Avenue
=^= Bethesda, Maryland 2CX}16
October 1, 1976
The Honorable Nelson A. Rockefeller
President of the United States Senate
United States Senate
Washington, D.C. 20510
Dear Mr. President:
On behalf of the National Commission for the Protection
of Human Subjects of Biomedical and Behavioral Research,
I am pleased to transmit our Report and Recommendations ;
Research Involving Prisoners" Under Public Law 93-348,
the Commission is charged to submit periodic reports to the
President, the Congress and the Secretary of Health, Educa-
tion, and Welfare on various aspects of research involving
human subjects, including the participation of prisoners in
biomedical and behavioral research.
The Commission's deliberations and recommendations to
the Congress and the Secretary, on research involving pris-
oners, as well as a summary of background materials, are
included in this volume. An appendix volume, containing
materials reviewed by the Commission in its deliberations,
will accompsLny the report.
The Commission has conducted extensive public delibera-
tions on the issues surroionding the involvement of prisoners
in research. These deliberations are reflected in our recom-
mendations, which we hope will provide a useful resolution
of this matter of public concern. We are grateful for the
opportunity to prepare the report.
Re/pectfuUy,
Itenneth J. R|
Chairman
National Commission for the Protection of Human Subjects
of Biomedical and Behavioral Research
Westwood Building, Room 125
5333 Westbcrd Avenue
= Bethesdo, Maryland 20016
October 1, 1976
The Honorable Carl Albert
Speaker of the House of Representatives
Washington, D.C. 20515
Dear Mr. Speaker:
On behalf of the National Commission for the Protection
of Human Subjects of Biomedical and Behavioral Research,
I am pleased to transmit our Report and Recomm.endations ;
Research Involving Prisoners" . Under Public Law 93-348,
the Commission is charged to submit periodic reports to the
President, the Congress and the Secretary of Health, Educa-
tion, and Welfare on various aspects of research involving
human subjects, including the participation of prisoners in
biomedical and behavioral research.
The Commission's deliberations and recommendations to
the Congress and the Secretary, on research involving pris-
oners, as well as a summary of background materials, are
included in this volume. An appendix volume, containing
materials reviewed by the Conamission in its deliberations,
will accompany the report.
The Commission has conducted extensive public delibera-
tions on the issues surrounding the involvement of prisoners
in research. These deliberations are reflected in our recom-
mendations, which we hope will provide a useful resolution
of this matter of public concern. We are gratefiil for the
opportunity to prepare the report.
Respectfully,
Kenneth J.
Chairman
, M.D.
National Commission for the Protection of Human Subjects
of Biomedical and Behavioral Research
Westwood Building, Room 125
5333 Westbard Avenue
- Bethesda, Maryland 20016
October 1, 1976
Honorable David Mathews
Secretary of Health, Education, and Welfare
Washington, D.C. 20201
Dear Mr. Secretary:
On behalf of the National Commission for the Protection
of Hximan Subjects of Biomedical and Behavioral Research,
I am pleased to transmit our Report and Recommendations ;
Research Involving Prisoners" Under Public Law 93-348,
the Commission is charged to submit periodic reports to the
President, the Congress and the Secretary of Health, Educa-
tion, and Welfare on various aspects of research involving
human subjects, including the participation of prisoners in
biomedical and behavioral research.
The Commission' s deliberations and recommendations to
the Congress and the Secretary, on research involving pris-
oners, as well as a summary of background materials, are
included in this volume. An appendix volume, containing
materials reviewed by the Commission in its deliberations,
will accompany the report.
The Commission has conducted extensive public delibera-
tions on the issues surrounding the involvement of prisoners
in research. These deliberations are reflected in our recom-
mendations, which we hope will provide a useful resolution
of this matter of public concern. We are grateful for the
opportunity to prepare the report.
ectfully.
.enneth J. Ryp^, M.D.
Chairman
NATIONAL COMMISSION FOR THE PROTECTION OF HUMAN SUBJECTS
OF BIOMEDICAL AND BEHAVIORAL RESEARCH
MEMBERS OF THE COMMISSION
Kenneth John Ryan, M.D., Chairman
Chief of Staff
Boston Hospital for Women
Joseph V. Brady, Ph.D.
Professor of Behavioral Biology
Johns Hopkins University
Robert E. Cooke, M.D.
Vice Chancellor for Health Sciences
University of Wisconsin
Karen Lebacqz, Ph.D.
Consultant in Bioethics
Department of Health
Sacramento, California
David W. Louise!!, J.D.
Professor of Law
University of California at Berkeley
Dorothy I. Height
President
National Council of Negro Women, Inc.
Donald W. Seldin, M.D.
Professor and Chairman
Department of Internal Medicine
University of Texas at Dallas
Albert R. Jonsen, Ph.D.
Associate Professor of Bioethics
University of California at San Francisco
Eliot Stellar, Ph.D.
Provost of the University and
Professor of Physiological Psychology
University of Pennsylvania
Patricia King, J.D.
Associate Professor of Law
Georgetown University Law Center
Robert H. Turtle, LL.B.
Attorney
VomBaur, Coburn, Simmons & Turtle
Washington, D. C.
NATIONAL COMMISSION FOR THE PROTECTION OF HUMAN SUBJECTS
OF BIOMEDICAL AND BEHAVIORAL RESEARCH
COMMISSION STAFF
Charles U. Lowe, M.D.
Executive Director
Michael S. Yesley, J.D.
Staff Director
PROFESSIONAL STAFF
SUPPORT STAFF
Duane Alexander, M.D.
Pediatrics
R. Anne Ballard, B.A.
Public Information Officer
Anthony Buividas, B.A.
Research Assistant
Lee Calhoun, M.A.
Political Science
Ronald S. Gass, M.A.
Research Assistant
Bradford Gray, Ph.D.
Sociology
Miriam Kelty, Ph.D.
Psychology
Bonnie M. Lee
Adnninistrative Assistant
Barbara Mishkin, M.A.
Bioethics
Stephen Toulmin, Ph.D.
Philosophy
Mary K. Ball
Pamela L. Driscoll
Lisa Gray
Marie D. Madigan
Lenora Odeku
Erma L. Pender
Susan F. Schreiber
SPECIAL CONSULTANT
Robert Levine, M.D.
PREFACE
The National Commission for the Protection of Human Subjects of Biomedical
and Behavioral Research was established under the National Research Act (P.L.
93-348) to develop ethical guidelines for the conduct of research involving
human subjects and to make recommendations for the application of such guide-
lines to research conducted or supported by the Department of Health, Education,
and Welfare (DHEW). The legislative mandate also directs the Commission to
make recommendations to Congress regarding the protection of human subjects
in research not subject to regulation by DHEW. Particular classes of subjects
that must receive the Commission's attention include children, prisoners and
the institutionalized mentally infirm.
The duties of the Commission with regard to research involving prisoners
are specifically set forth in section 202(a)(2) of the National Research Act,
as follows:
The Commission shall identify the requirements for
informed consent to participation in biomedical and
behavioral research by prisoners The Commission
shall investigate and study biomedical and behavioral
research conducted or supported under programs admin-
istered by the Secretary [DHEW] and involving pris-
oners to determine the nature of the consent ob-
tained from such persons or their legal representatives
before such persons were involved in such research; the
adequacy of the information given them respecting the
nature and purpose of the research, procedures to be
used, risks and discomforts, anticipated benefits
from the research, and other matters necessary for
informed consent; and the competence and the freedom
of the persons to make a choice for or against involve-
ment in such research. On the basis of such investi-
gation and study the Commission shall make such recom-
mendations to the Secretary as it determines appropriate
to assure that biomedical and behavioral research con-
ducted or supported under programs administered by him
meets the requirements respecting informed consent
identified by the Commission.
vn
This responsibility is broadened by the provision (section 202(a)(3)) that the
Commission make recommendations to Congress regarding the protection of subjects
involved in research not subject to regulation by DHEW, such as research in-
volving prisoners that is conducted or supported by other federal departments
or agencies, as well as research conducted in federal prisons or involving
inmates from such prisons.
To carry out its mandate, the Commission studied the nature and extent of
research involving prisoners, the conditions under which such research is con-
ducted, and the possible grounds for continuation, restriction or termination
of such research. Commission members and staff made site visits to four prisons
and two research facilities outside prisons that use prisoners, in order to ob-
tain first-hand information on the conduct of biomedical research and the
operation of behavioral programs in these settings. During the visits, inter-
views were conducted with many inmates who have participated in research or
behavioral programs as well as with nonpartici pants.
The Commission held a public hearing at which research scientists, pris-
oner advocates and providers of legal services to prisoners, representatives
of the pharmaceutical industry, and members of the public presented their views
on research involving prisoners. This hearing was duly announced, and no re-
quest to testify was denied. The National Minority Conference on Human Experi-
mentation, which was convoked by the Commission in order to assure that view-
points of minorities would be expressed, made recommendations to the Commission
on research in prisons. In addition to papers, surveys and other materials
prepared by the Commission staff, studies on the following topics were prepared
vm
under contract: (1) alternatives to the involvement of prisoners; (2) foreign
practices with respect to drug testing; (3) philosophical, sociological and
legal perspectives on the involvement of prisoners in research; (4) behavioral
research involving prisoners; and (5) a survey of research review procedures,
investigators and prisoners at five prisons. Finally, at public meetings com-
mencing in January 1976, the Commission conducted extensive deliberations and
developed its recommendations on the involvement of prisoners in research.
Part I of this report contains the recommendations as well as the
deliberations and conclusions of the Commission and a summary of background
materials. The nature and extent of research involving prisoners are des-
cribed in Part II. The activities of the Commission and reports that were
prepared for it are summarized in Parts III and IV, respectively. An appen-
dix to this report contains papers, surveys, reports and other materials that
were prepared or collected for the Commission on various topics related to
research involving prisoners. Most of such materials are summarized in
Part IV of the report.
Glossary of Terms Used in this Report .
Phases of drug testing . FDA regulations require three phases for the
testing of new drugs. Phase 1 is the first introduction of a new drug into
humans (using normal volunteers), with the purpose of determining human
toxicity, metabolism, absorption, elimination and other pharmacological
action, preferred route of administration and safe dosage range. Phase 2
covers the initial trials on a limited number of patients for specific
IX
disease control or prophylaxis purposes. Phase 3 involves extended clinical
trials, providing assessment of the drug's safety and effectiveness and
optimum dosage schedules in the diagnosis, treatment or prophylaxis of
groups of subjects involving a given disease or condition. (Source: 21
C.F.R. 312.1)
Prison . "Any place for the confinement or rehabilitation of juvenile
offenders or individuals charged with or convicted of criminal offenses"
(42 U.S.C. 3781).
Prisoner . Any individual involuntarily confined in a prison.
Therapeutic research, nontherapeutic research . The Commission recognizes
problems with employing the terms "therapeutic" and "nontherapeutic" research,
notwithstanding their common usage, because they may convey a misleading im-
pression. Research refers to a class of activities designed to develop
general izable new knowledge. Such activities are often engaged in to learn
something about practices designed for the therapy of the individual. Such
research is often called "therapeutic" research; however, the research is not
solely for the therapy of the individual. In order to do research, additional
interventions over and above those necessary for therapy may need to be done,
e.g. , randomization, blood drawing, catheterization; these interventions may
not be "therapeutic" for the individual. Some of these interventions may
themselves present risk to the individual — risk unrelated to the therapy of
the subject. The Commission has employed the term "research on practices
which have the intent and reasonable probability of improving the health or
well-being of the subject" or variants of this term. Since the reports pre-
pared for the Commission by outside contractors or consultants generally
employ the terms in common usage, such terms have been retained in the sum-
maries of those reports.
XI
TABLE OF CONTENTS
Preface
Part I. Deliberations, Conclusions and Recommendations
Chapter 1. Deliberations and Conclusions 1
2 . Recommendati ons 14
Part II. Background
3. Nature of Research Involving Prisoners 23
4. Extent of Research Involving Prisoners 29
Part III. Activities of the Commission
5. Site Visits to Prisons 33
6. National Minority Conference on Human
Experimentation 41
7. Public Hearing 44
Part IV. Reports to the Commission
8. Philosophical Perspectives 49
9. Sociological and Behavioral Perspectives 56
10. Legal Perspectives 61
11. Alternatives and Foreign Practices 65
12. Survey of Review Procedures,
Investigators and Prisoners 75
PART I. DELIBERATIONS, CONCLUSIONS AND RECOMMENDATIONS
Chapter 1. Deliberations and Conclusions .
Introduction . Prior to 1940, prisoners in the United States seldom
participated in biomedical research that had no reasonable expectation of im-
proving the health or well-being of the research subjects. During World War
II, however, large numbers of prisoners participated in voluntary research
programs to develop treatment for infectious diseases that afflicted our
armed forces. This involvement of prisoners was considered to be not only
acceptable, but praiseworthy. Following the war, the growth of biomedical
research and the imposition of requirements for testing drugs as to safety
led to the increased use of prisoners. Their participation in biomedical
research not related to their health or well-being has continued in this
country to the present time. This participation is now primarily in phase 1
drug and cosmetic testing, which is conducted or supported by pharmaceutical
manufacturers in connection with applications to the Food and Drug Adminis-
tration for licensing new drugs. Other research of this sort in which pris-
oners participate, or have participated, includes studies of normal metabolism
and physiology, conducted by the Public Health Service (PHS); studies of the
prevention or treatment of infectious diseases, conducted or supported by the
PHS and the Department of Defense; a study of the effects of irradiation on
the male reproductive function, supported by the Atomic Energy Commission;
and testing of the addictive properties of new analgesics by giving them to
prisoners with a history of narcotic abuse, conducted at the Addiction Research
Center in Lexington, Kentucky. (The involvement of federal prisoners in the
Lexington program is scheduled to be phased out.*)
* Letter dated March 1, 1976 to Honorable Robert W. Kastenmeier from Norman A.
Carlson, Director, U.S. Bureau of Prisons.
1
Prisoners also participate in research on practices that have the intent
,id reasonable probability of improving their health or well-being. This
research includes, for example, studies (supported by various components of
DHEW and the Federal Bureau of Prisons) to develop methods to reduce the
spread of infections, improve dental care, help the subjects stop smoking
and remove tatoos. A major focus of this sort of research involving federal
prisoners has been the development of new treatments for narcotic addiction.
A third type of research in which prisoners participate includes studies
of the possible causes, effects and process of incarceration, and studies of
prisons as institutional structures or of prisoners as incarcerated persons.
Components of DHEW have undertaken research of this sort for such purposes
as learning the etiology of drug addiction and deviant or self-destructive
behavior, and the factors relating to parole performance and recidivism.
Research is also conducted on the methods of treatment or "rehabilitation"
of prisoners. The National Institute of Mental Health, the Federal Bureau of
Prisons, and the Law Enforcement Assistance Administration have supported
research on the experimental treatment of aggressive behavior with drugs and
aversive conditioning techniques, as well as behavior modification based upon
depriving inmates of basic amenities which they must then earn back as privi-
leges. Rehabilitative practices have not always been based upon prior scien-
tific design and evaluation, however, despite the fact that there are few,
if any, approaches to the treatment or rehabilitation of prisoners for which
effectiveness has been clearly demonstrated.
Outside the United States prisoners do not generally participate in bio-
medical research. This exclusion may be ascribed in part to continuing concern
over experiments that were conducted on prisoners in Nazi concentration camps.
Revelations of those experiments led to the enunciation of the Nuremberg Code
(1946-1949), which required that human subjects of research "be so situated
as to be able to exercise free power of choice" but did not expressly pro-
hibit research involving civil prisoners. The Declaration of Helsinki,
adopted by the World Medical Association in 1964 and endorsed by the American
Medical Association in 1966, contained similar language that was subsequently
deleted in 1975. Although little if any drug testing is conducted in foreign
prisons, other kinds of research have been conducted in prisons throughout
the world, such as studies dealing with the incidence and implications of
chromosome abnormalities.
Since the 1960's, the ethical propriety of participation by prisoners
in research has increasingly been questioned in this country. Among the
events that have focused public attention on this issue was the publication
of Jessica Mitford's book. Kind and Usual Punishment , in 1973. Eight states
and the Federal Bureau of Prisons have formally moved to abandon research in
prisons. The Health Subcommittee of the Senate Committee on Labor and Public
Welfare held hearings ( Quality of Health Care - Human Experimentation, 1973 )
on research involving prisoners in late 1973. Those speaking against the use
of prisoners cited exploitation, secrecy, danger and the impossibility of
obtaining informed consent as reasons to impose a prohibition or moratorium
on the conduct of research in prisons. The advantages of using prisoners in
research ( e.g. , opportunity for close monitoring and controlled environment)
and the procedures that are employed to protect prisoner participants were
also described in the hearings. The Health Subcommittee held extensive
hearings on other areas of human experimentation as well, and reported the
bill establishing this Commission with a mandate that included a directive
to study and make recommendations concerning the involvement of prisoners
in research.
More recently, the House Subcommittee on Courts, Civil Liberties, and the
Administration of Justice held hearings ( Prison Inmates in Medical Research ,
1975) on a bill (H.R. 3603) to prohibit "medical research" in federal prisons
and prisons of states that receive certain federal support. Following these
hearings, the Director of the Federal Bureau of Prisons determined that
"continued use of prisoners in any medical experimentation should not be
permitted," and he ordered that such participation by prisoners under federal
jurisdiction be phased out.
Some of the more extreme behavioral programs have also raised questions.
In her 1973 book, Jessica Mitford expressed concern about new approaches to
"treatment" for offenders. Concurrently, others raised questions about the
use of psychosurgery in prisons. In the early 1970' s, the first challenges
to behavior modification and aversive conditioning programs in prisons were
argued in the courts, with mixed results. Most of the cases involved the
right to refuse to participate in such programs, although prisoners have
also petitioned for the right to be included in programs designed to alter
sexually aggressive behavior.
Concern over behavior modification programs in prisons was expressed
in a study. Individual Rights and the Federal Role in Behavior Modification
(1974), prepared by the staff of the Constitutional Rights Subcommittee of the
Senate Judiciary Committee. The study contained information on a number of
such programs and suggested that this Commission make use of the information
in attempting to resolve the issues that they raised. It should be noted
that a number of the "treatment" programs mentioned in the study are reported
to have been discontinued.
General concerns . In conducting its investigations and studies, the
Commission has noted and cannot ignore serious deficiencies in living condi-
tions and health care that generally prevail in prisons. Nor can the Commission
ignore the potential for arbitrary exercise of authority by prison officials
and for unreasonable restriction of communication to and from prisoners. The
Commission, although acknowledging that it has neither the expertise nor the
mandate for prison reform, nevertheless urges that unjust and inhumane condi-
tions be eliminated from all prisons, whether or not research activities are
conducted or contemplated.
Ethical considerations about using prisoners as research subjects . There
are two basic ethical dilemmas concerning the use of prisoners as research sub-
jects: • (1) whether prisoners bear a fair share of the burdens and receive a
fair share of the benefits of research; and (2) whether prisoners are, in the
words of the Nuremberg Code, "so situated as to be able to exercise free power
of choice" -- that is, whether prisoners can give truly voluntary consent to
participate in research.
These two dilemmas relate to two basic ethical principles: the principle
of justice , which requires that persons and groups be treated fairly, and the
principle of respect for persons , which requires that the autonomy of persons
be promoted and protected. Disproportionate use of prisoners in certain
kinds of research ( e.g. , phase 1 drug testing) would constitute a violation
of the first principle; closed and coercive prison environments would com-
promise the second principle. It is within the context of a concern to im-
plement these principles that the Commission has deliberated the question
of use of prisoners as research subjects.
The Commission recognizes, however, that the application of these
principles to the problem is not unambiguous. To respect a person is to
allow that person to live in accord with his or her deliberate choices.
Since the choices of prisoners in all matters except those explicitly with-
drawn by law should be respected, as courts increasingly affirm, it seems
at first glance that the principle of respect for persons requires that
prisoners not be deprived of the opportunity to volunteer for research.
Indeed, systematic deprivation of this freedom would also violate the prin-
ciple of justice, since it would arbitrarily deprive one class of persons
of benefits available to others--namely, the benefits of participation in
research.
However, the application of the principles of respect and justice allows
another interpretation, which the Commission favors. When persons seem regu-
larly to engage in activities which, were they stronger or in better circum-
stances, they would avoid, respect dictates that they be protected against
those forces that appear to compel their choices. It has become evident to
the Commission that, although prisoners who participate in research affirm
that they do so freely, the conditions of social and economic deprivation in
which they live compromise their freedom. The Commission believes, therefore,
that the appropriate expression of respect consists in protection from exploita-
tion. Hence it calls for certain safeguards intended to reduce the elements of
constraint under which prisoners give consent and suggests that certain kinds
of research would not be permitted where such safeguards cannot be assured.
Further, a concern for justice raises the question whether social insti-
tutions are so arranged that particular persons or groups are burdened with
marked disadvantages or deprived of certain benefits for reasons unrelated to
their merit, contribution, deserts or need. While this principle can be inter-
preted, as above, to require that prisoners not be unjustly excluded from
participation in research, it also requires attention to the possibility that
prisoners as a group bear a disproportionate share of the burdens of research
or bear those burdens without receiving a commensurate share of the benefits
that ultimately derive from research. To the extent that participation in
research may be a burden, the Commission is concerned to ensure that this
burden not be unduly visited upon prisoners simply because of their captive
status and administrative availability. Thus it specifies some conditions
for the selection of prisoners as a subject pool for certain kinds of research.
In so doing, the Commission is not primarily intending to protect prisoners
from the risks of research; indeed, the Commission notes that the risks of
research, as compared with other kinds of occupations, may be rather small.
The Commission's concern, rather, is to ensure the equitable distribution of
the burdens of research no matter how large or small those burdens may be.
The Commission is concerned that the status of being a prisoner makes possible
the perpetration of certain systemic injustices. For example, the availability
of a population living in conditions of social and economic deprivation makes
it possible for researchers to bring to these populations types of research
which persons better situated would ordinarily refuse. It also establishes
an enterprise whose fair administration can be readily corrupted by prisoner
control or arbitrarily manipulated by prison authorities. And finally, it
allows an inequitable distribution of burdens and benefits, in that those
social classes from which prisoners often come are seldom full beneficiaries
of improvements in medical care and other benefits accruing to society from
the research enterprise.
Reflection upon these principles and upon the actual conditions of
imprisonment in our society has led the Commission to believe that prisoners
are, as a consequence of being prisoners, more ;subject to coerced choice and
more readily available for the imposition of burdens which others will not
willingly bear. Thus, it has inclined toward protection as the most appro-
priate expression of respect for prisoners as persons and toward redistri-
bution of those burdens of risk and inconvenience which are presently con-
centrated upon prisoners. At the same time, it admits that, should coercions
be lessened and more equitable systems for the sharing of burdens and benefits
be devised, respect for persons and concern for justice would suggest that
prisoners not be deprived of the opportunity to participate in research. Con-
cern for principles of respect and justice leads the Commission to encourage
those forms of inquiry that could form a basis for improvement of current
prison conditions and practices, such as studies of the effects of incarcera-
tion, of prisons as institutions and of prisoners as prisoners, and also to
allow research on practices clearly intended to improve the health or well-being
of individual prisoners.
The Commission has noted the concern, expressed by participants at the
National Minority Conference and by others, that minorities bear a dispro-
portionate share of the risks of research conducted in prisons. This concern
is fostered, in part, by evidence that prison populations are disproportionately
nonwhite. Evidence presented to the Conmission indicates that where research
is done in prison, those prisoners who participate tend to be predominantly
white, even in institutions where the population as a whole is predominantly
nonwhite; further, those who participate in research tend to be better edu-
cated and more frequently employed at better jobs than the prison population
as a whole. This evidence suggests that nonwhites and poor or less educated
persons in prison do not carry a greater share of the burdens of research.
However, the evidence is inconclusive for two reasons: first, because
it does not fully satisfy questions related to the risks of research; and
second, because it raises questions of justice with respect to the equitable
distribution of benefits (as well as burdens) of research.
With respect to risks, the Commission notes that different research
projects carry different risks; it is possible, though the Commission has no
evidence to this effect, that one race or another may participate in more
research of higher risk. And of course, the ratio of nonwhites to whites
participating in research and hence bearing the burdens of research may
still be disproportionate when compared to the ratio of the populations as
a whole.
But the Commission also notes that those who participate in research
consider the benefits sufficient to outweigh the burdens. Thus, the greater
participation of whites may mean that there is an inequitable distribution
of benefits between racial groups. Hence the greater participation by
whites does not necessarily resolve the issue of distributive justice.
Similarly, the Commission notes that less research is conducted in
women's prisons. While the reasons for this may well be the same reasons
that women in general are used less frequently than men as research subjects
( e.g. , the possibility of pregnancy), questions of distributive justice,
similar to those raised above, may still need to be addressed with respect
to participation in research by women prisoners.
Discussion . Among the issues discussed by the Commission are two on
which no specific recommendations are made, but concerning which the considera-
tions of the Commission should be expressed: (1) remuneration, and (2)
alternatives to conducting research in prisons. (1) Remuneration is a sub-
ject that should be analyzed by human subjects review committees, in consulta-
tion with prison grievance committees and prison authorities. There are at
least two considerations that must be balanced in the determination of appro-
priate rates for participation in research not related to the subjects' health
or well-being. On the one hand, the pay offered to prisoners should not be so
high, compared to other opportunities for employment within the facility, as
to constitute undue inducement to participate. On the other hand, those who
sponsor the research should not take economic advantage of captive populations
by paying significantly less than would be necessary if nonprisoner volunteers
were recruited. Fair solutions to this problem are difficult to achieve. One
suggestion is that those who sponsor research pay the same rate for prisoners
10
as they pay other volunteers, but that the amount actually going to the
research subjects be comparable to the rates of pay otherwise available within
the facility. The difference between the two amounts could be paid into a
general fund, either to subsidize the wages for all inmates within the prison,
or for other purposes that benefit the prisoners or their families. Prisoners
should participate in managing such a fund and in determining allocation of
the monies. Another suggestion is that the difference be held in escrow and
paid to each participant at the time of release or, alternatively, that it be
paid directly to the prisoner's family.
A requirement related to the question of appropriate remuneration for
participation in research is that prisoners should be able to obtain an ade-
quate diet, the necessities of personal hygiene, medical attention and income
without recourse to participation in research.
(2) Some of the Commission members endorse the alternative of permitting
prisoners to participate in research provided it is conducted in a clinic or
hospital outside the prison grounds, and provided also that nonprisoners parti-
cipate in the same projects for the same wages. Other members of the Commission
believe that such a mechanism would serve only to increase the disparity between
the conditions within the prison and those within the research unit, thereby
heightening the inducement to participate in research in order to escape from
the constraints of the prison setting. All of the members of the Commission
endorse the suggestion that the use of alternative populations be explored and
utilized more fully than is presently the case. This may be especially important
to permit drugs to continue to be tested, as required by current law and regu-
lations of the FDA, during any period in which prisons have not satisfied the
11
conditions that are recommended for the conduct of such research. Increased
utilization of alternative populations would have the added benefit of pro-
viding nonprisoner populations to participate in research projects along
with prisoners, or in parallel with similar projects within prisons, in
order to satisfy the general concern that prisoners not participate in experi-
ments that nonprisoners would find unacceptable. The Commission also suggests
that Congress and the FDA consider the advisability of undertaking a study
and evaluation to determine whether present requirements for phase 1 drug
testing in normal volunteers should be modified.
Conclusions . In the course of its investigations and review of evidence
presented to it, the Commission did not find in prisons the conditions requisite
for a sufficiently high degree of voluntariness and openness, notwithstanding
that prisoners currently participating in research consider, in nearly all in-
stances, that they do so voluntarily and want the research to continue. The
Commission recognizes the role that research involving prisoners has played.
It does not consider, however, that administrative convenience or availability
of subjects is, in itself, sufficient justification for selecting prisoners
as subjects.
Throughout lengthy deliberations, the strong evidence of poor conditions
generally prevailing in prisons and the paucity of evidence of any necessity
to conduct research in prisons have been significant considerations of the
Commission. An equally important consideration has been the closed nature of
prisons, with the resulting potential for abuse of authority. Some of the Com-
mission members, who are opposed to research not related to the health or well
being of prisoner-participants, have, however, agreed to permit it to be con-
12
ducted, but only under the following standards: adequate living conditions,
separation of research participation from any appearance of parole considera-
tion, effective grievance procedures and public scrutiny at the prison where
research will be conducted or from which prospective subjects will be taken;
importance of the research; compelling reasons to involve prisoners; and fair-
ness of such involvement. Compliance with these requirements must be certi-
fied by the highest responsible federal official, assisted by a national
ethical review body. The Commission has concluded that the burden of proof
that all the requirements are satisfied should be on those who wish to con-
duct the research.
13
Chapter 2. Recommendations -
The National Commission for the Protection of Human Subjects of Biomedical
and Behavioral Research makes the following recommendations on research involving
prisoners, to:
(i) The Secretary, DHEW, with respect to research that is subject to his
regulation, i.e. , research conducted or supported under programs administered
by him and research reported to him in fulfillment of regulatory requirements;
and
(ii) The Congress, except as otherwise noted, with respect to research
that is not subject to regulation by the Secretary, DHEW.
Recommendation (1): STUDIES OF THE POSSIBLE CAUSES, EFFECTS AND PROCESSES
OF INCARCERATION AND STUDIES OF PRISONS AS INSTITUTIONAL STRUCTURES OR OF PRIS-
ONERS AS INCARCERATED PERSONS MAY BE CONDUCTED OR SUPPORTED, PROVIDED THAT (A)
THEY PRESENT MINIMAL OR NO RISK AND NO MORE THAN MERE INCONVENIENCE TO THE
SUBJECTS, AND (B) THE REQUIREMENTS UNDER RECOMMENDATION (4) ARE FULFILLED.
Comment: The Commission encourages the conduct of studies of prisons
as institutions and prisoners as incarcerated persons. Because the inadequacies
of the prisons may themselves be the object of such studies, the Commission has
not set any conditions for the conduct of such research other than a limitation
of this category to research that presents minimal or no risk and no more than
mere inconvenience, and the requirements of Recommendation (4)
Studies of prisoners consisting of questionnaires, surveys, analyses
of census and demographic data, psychological tests, personality inventories
14
and the like rarely involve risk and are essential for proper understanding
of prisons and the effects of their practices. Research designed to deter-
mine the effects on general health of institutional diets and restricted acti-
vity, and similar studies that do not manipulate bodily conditions (except
innocuously, e.g. , obtaining blood samples) but merely monitor or analyze
such conditions, also present little physical risk and are necessary to gain
some knowledge of the effects of imprisonment. Such research is a necessary
step toward understanding prison practices and alternatives, without which
there can be no improvement.
Recommendation (2): RESEARCH ON PRACTICES, BOTH INNOVATIVE AND ACCEPTED,
WHICH HAVE THE INTENT AND REASONABLE PROBABILITY OF IMPROVING THE HEALTH OR
WELL-BEING OF THE INDIVIDUAL PRISONER MAY BE CONDUCTED OR SUPPORTED, PROVIDED
THE REQUIREMENTS UNDER RECOMMENDATION (4) ARE FULFILLED.
Comment: Research would fall under this recommendation if the practices
under study are designed solely to improve the health or well-being of the
research subject by prophylactic, diagnostic or treatment methods that may
depart from standard practice but hold out a reasonable expectation of success.
The Commission intends that prisoners not be discriminated against with respect
to research protocols in which a therapeutic result might be realized for the
individual subject. The committees that review all research involving prisoners
should analyze carefully any claims that research projects are designed to im-
prove the health or well-being of subjects and should be particularly cautious
with regard to research in which the principal purpose of the practice under
study is to enforce conformity with behavioral norms established by prison
officials or even by society. Such conformity cannot be assumed to improve
15
the condition of the individual prisoner. If the review committee does not
consider such claims to be sufficiently substantiated, the research should
not be conducted unless it conforms to the requirements of Recommendation (3).
Recommendation (3): EXCEPT AS PROVIDED IN RECOMMENDATION (1) AND (2),
RESEARCH INVOLVING PRISONERS SHOULD NOT BE CONDUCTED OR SUPPORTED, AND REPORTS
OF SUCH RESEARCH SHOULD NOT BE ACCEPTED BY THE SECRETARY, DHEW, IN FULFILLMENT
OF REGULATORY REQUIREMENTS, UNLESS THE REQUIREMENTS UNDER RECOMMENDATION (4)
ARE FULFILLED AND THE HEAD OF THE RESPONSIBLE FEDERAL DEPARTMENT OR AGENCY HAS
CERTIFIED, AFTER CONSULTATION WITH A NATIONAL ETHICAL REVIEW BODY. THAT THE
FOLLOWING THREE REQUIREMENTS ARE SATISFIED:
(A) THE TYPE OF RESEARCH FULFILLS AN IMPORTANT SOCIAL AND SCIENTIFIC
NEED, AND THE REASONS FOR INVOLVING PRISONERS IN THE TYPE OF
RESEARCH ARE COMPELLING;
(B) THE INVOLVEMENT OF PRISONERS IN THE TYPE OF RESEARCH SATISFIES
CONDITIONS OF EQUITY; AND
(C) A HIGH DEGREE OF VOLUNTARINESS ON THE PART OF THE PROSPECTIVE
PARTICIPANTS AND OF OPENNESS ON THE PART OF THE INSTITUTION(S) TO
BE INVOLVED WOULD CHARACTERIZE THE CONDUCT OF THE RESEARCH; MINIMUM
REQUIREMENTS FOR SUCH VOLUNTARINESS AND OPENNESS INCLUDE ADEQUATE
LIVING CONDITIONS, PROVISIONS FOR EFFECTIVE REDRESS OF GRIEVANCES,
SEPARATION OF RESEARCH PARTICIPATION FROM PAROLE CONSIDERATIONS,
AND PUBLIC SCRUTINY.
Comment: Detailed standards expressing the intent of the Commission with
respect to Requirement (C) of this Recommendation are as follows:
16
(i) Public scrutiny . Prisoners should be able to communicate, without
censorship, with persons outside the prison and, on a privileged, confidential
basis, with attorneys, legal organizations which assist prisoners, the accred-
iting office which assists the certifying federal official or national ethical
review body, the grievance conmittee referred to in paragraph (ii) below, and
the human subjects review committee or institutional review board referred to
in Recommendation (4). Each of such persons or organizations with whom pris-
oners should be able to communicate on a privileged, confidential basis should
be able to conduct private interviews with any prisoner who so desires. The
accrediting office, grievance committee and human subjects review committee or
institutional review board should be allowed free access to the prison.
(ii) Grievance procedures . There should exist a grievance committee
composed of elected prisoner representatives, prisoner advocates and repre-
sentatives of the community. The committee should enable prisoners to obtain
effective redress of their grievances and should facilitate inspections and
monitoring by the accrediting office to assure continuing compliance with re-
quirement (C).
(iii) Standard of living . Living conditions in the prison in which research
will be conducted or from which subjects will be recruited should be adequate,
as evidenced by compliance with all of the following standards:
(1) The prison population does not exceed designed capacity, and
each prisoner has an adequate amount of living space;
(2) There are single occupancy cells available for those who desire
them;
17
(3) There is segregation of offenders by age, degree of violence,
prior criminal record, and physical and mental health require-
ments;
(4) There are operable cell doors, emergency exists and fire extin-
guishers, and compliance with state and local fire and safety
codes is certified;
(5) There are operable toilets and wash basins in cells;
(6) There is regular access to clean and working showers;
(7) Articles of personal care and clean linen are regularly issued;
(8) There are adequate recreation facilities, and each prisoner
is allowed an adequate amount of recreation;
(9) There are good quality medical facilities in the prison, ade-
quately staffed and equipped, and approved by an outside medical
accrediting organization such as the Joint Commission on Accredita-
tion of Hospitals or a state medical society;
(10) There are adequate mental health services and professional staff;
(11) There is adequate opportunity for prisoners who so desire to
work for remuneration comparable to that received for partici-
pation in research;
(12) There is adequate opportunity for prisoners who so desire to
receive education and vocational training;
(13) Prisoners are afforded opportunity to communicate privately with
their visitors, and are permitted frequent visits;
(14) There is a sufficiently large and well-trained staff to provide
assurance of prisoners' safety;
18
(15) The racial composition of the staff is reasonably concordant
with that of the prisoners;
(16) To the extent that it is consistent with the security needs
of the prison, there should be an opportunity for inmates to
lock their own cells; and
(17) Conditions in the prison satisfy basic institutional environ-
mental health, food service and nutritional standards.
(iv) Parole . There should be effective procedures assuring that parole
boards cannot take into account prisoners' participation in research and that
prisoners are clearly informed that there is absolutely no relationship between
research partcipation and determinations by their parole boards.
If an investigator wishes to present evidence of the importance and fair-
ness of conducting a type of research on a prison population (requirements (A)
and (B)) and proposes that the conditions of voluntariness and openness would
be satisfied at a particular prison (requirement (C)), the case should be
presented to the Secretary, DHEW (or the head of any other department or agency
under whose authority the research would be conducted). Such official should
seek the advice of an existing or newly created advisory body (such as the
Ethical Advisory Board established within the Public Health Service) in deter-
mining whether to approve the type of research at the specific institution.
Such official or advisory body should be assisted by an accrediting office,
which makes inspections, certifies compliance with requirement (C), and moni-
tors continuing compliance of any prison involved in research. In determining
such compliance, the accrediting office should be guided by the above descrip-
tion of the Commission's intent in recommending requirement (C).
19
Reconmendation (4): (A) THE HEAD OF THE RESPONSIBLE FEDERAL DEPARTMENT
OR AGENCY SHOULD DETERMINE THAT THE COMPETENCE OF THE INVESTIGATORS AND THE
ADEQUACY OF THE RESEARCH FACILITIES INVOLVED ARE SUFFICIENT FOR THE CONDUCT
OF ANY RESEARCH PROJECT IN WHICH PRISONERS ARE TO BE INVOLVED.
(B) ALL RESEARCH INVOLVING PRISONERS SHOULD BE REVIEWED BY AT
LEAST ONE HUMAN SUBJECTS REVIEW COMMITTEE OR INSTITUTIONAL REVIEW BOARD COM-
PRISED OF MEN AND WOMEN OF DIVERSE RACIAL AND CULTURAL BACKGROUNDS THAT IN-
CLUDES AMONG ITS MEMBERS PRISONERS OR PRISONER ADVOCATES AND SUCH OTHER PER-
SONS AS COMMUNITY REPRESENTATIVES, CLERGY, BEHAVIORAL SCIENTISTS AND MEDICAL
PERSONNEL NOT ASSOCIATED WITH THE CONDUCT OF THE RESEARCH OR THE PENAL INSTI-
TUTION; IN REVIEWING PROPOSED RESEARCH, THE COMMITTEE OR BOARD SHOULD CONSIDER
AT LEAST THE FOLLOWING: THE RISKS INVOLVED, PROVISIONS FOR OBTAINING INFORMED
CONSENT, SAFEGUARDS TO PROTECT INDIVIDUAL DIGNITY AND CONFIDENTIALITY, PRO-
CEDURES FOR THE SELECTION OF SUBJECTS, AND PROVISIONS FOR PROVIDING COMPEN-
SATION FOR RESEARCH-RELATED INJURY.
Comment: The risks involved in research involving prisoners should be
commensurate with risks that would be accepted by nonprisoner volunteers.
If it is questionable whether a particular project is offered to prisoners
because of the risk involved, the review committee might require that non-
prisoners be included in the same project.
In negotiations regarding consent, it should be determined that the
written or verbal comprehensibility of the information presented is appro-
priate to the subject population.
20
Procedures for the selection of subjects within the prison should be
fair and immune from arbitrary intervention by authorities or prisoners.
Compensation and treatment for research-related injury should be pro-
vided, and the procedures for requesting such compensation and treatment
should be described fully on consent forms retained by the subjects.
Prisoners who are minors, mentally disabled or retarded should not
be included as subjects unless the research is related to their particular
condition and complies with the standards for research involving those groups
as well as those for prisoners. (Recommendations concerning research parti-
cipation of children and the institutionalized mentally infirm will here-
after be made by the Commission.)
There should be effective procedures assuring that parole boards cannot
take into account prisoners' participation in research, and that prisoners
are made certain that there is absolutely no relationship between research
participation and determinations by their parole boards.
Recommendation (5): IN THE ABSENCE OF CERTIFICATION THAT THE REQUIREMENTS
UNDER RECOMMENDATION (3) ARE SATISFIED, RESEARCH PROJECTS COVERED BY THAT
RECOMMENDATION THAT ARE SUBJECT TO REGULATION BY THE SECRETARY, DHEW, AND ARE
CURRENTLY IN PROGRESS SHOULD BE PERMITTED TO CONTINUE NOT LONGER THAN ONE
YEAR FROM THE DATE OF PUBLICATION OF THESE RECOMMENDATIONS IN THE FEDERAL
REGISTER OR UNTIL COMPLETED, WHICHEVER IS EARLIER.
21
PART II. BACKGROUND
Chapter 3. Nature of Research Involving Prisoners
Research activities involving prisoners may be divided into four broad
categories: biomedical research not related to the health or well-being of
the subject, biomedical research on practices intended to improve the health
or well-being of the subject, social research, and behavioral research on
practices intended to improve the health or well-being of the subject. The
first category of research using prisoners mainly involves phase 1 testing
of new drugs and testing of vaccines as to efficacy. Biomedical and behavioral
research related to the health or well-being of the prisoner-participants
generally involves the study of conditions associated with prisoners or prisons.
In addition, innovative practices in prisons, intended to rehabilitate or treat
prisoners, often have many attributes of behavioral research but are seldom
introduced as such. The major controversy over participation of prisoners
surrounds their use as subjects of biomedical research not related to their
health or well-being and their unwilling involvement in experimental treatment
or rehabilitative programs.
Biomedical research unrelated to the health or well-being of prisoner-
participants was conducted in the United States only in isolated instances
prior to the establishment in 1934 of a program at Leavenworth Prison to assess
the abuse potential of narcotic analgesics; such research is now conducted at
the Addiction Research Center in Lexington, Kentucky, although it was announced
recently that the program will be terminated by the end of 1976. The current
involvement of prisoners in biomedical research unrelated to their health or
23
well-being can be traced to three sources. First, during World War II, pris-
oners volunteered in large numbers for studies, such as those to develop
effective anti-malarial drugs, which were viewed as contributing to the national
interest. Reviews of these prison research activities by several state commis-
sions resulted in their endorsement. In fact, prisoner participation in re-
search was felt to be such a salutary experience that the American Medical
Association formally opposed allowing persons convicted of particularly serious
crimes to have the privilege of participating in scientific experiments. Second,
the enthusiastic support of biomedical research by the government and the public
following the war brought an enormous growth to research enterprises, and pris-
oners served as subjects in many of these new endeavors. Third, the thalidomide
experience was followed by passage in 1962 of the Kefauver-Harris amendments to
the Food and Drug Act, which established additional requirements for testing the
safety and efficacy of all drugs to be sold in interstate commerce and thereby
encouraged the continued use of prisoners in research. The phase 1 testing
requirements established under these amendments required evaluation of the
safety of new drugs in normal volunteers under controlled conditions, and pris-
oners became the population on which much of this testing was performed.
Innovative prison practices are often difficult to distinguish from what
might be termed behavioral research on practices intended to improve the health
or well-being of prisoner-participants. Since the early 1900's, innovations
such as flexible sentences, indeterminate sentences, behavioral therapies
during imprisonment, and parole and probation based on evidence of rehabili-
tation have been introduced into the prison system. These innovations have
not generally included provisions for design, review and evaluation as research..
24
Frequently, though, the behavioral programs have had many characteristics of
behavior modification research. Examples range from use of "therapeutic
community" and reinforcement techniques in prison, to use of aversive condi-
tioning (employing electric shock or drugs with unpleasant effects) in treating
sex offenders or uncontrollably violent prisoners, to use of a structured tier
system (token economy) in which a prisoner progresses from living conditions
of severe deprivation to relative freedom and comfort as a reward for socially
acceptable behavior. At the extreme of research or treatment designed to change
behavior were castration for sexual offenders and psychosurgery for uncontrolla-
ble violence.
The peak of enthusiasm for the application of behavior modification
techniques in the prison system was marked by the establishment of the Special
Treatment and Rehabilitation Training (START) program in the Federal Bureau
of Prisons, and the planning of a new federal prison at Butner, North Carolina,
with research in applying behavioral modification throughout a prison as its
primary purpose. The START program was abandoned, after ^h years of operation,
under considerable criticism and after some challenges in court. Similar acti-
vities led to a reevaluation of the programs planned for Butner, which opened
in May 1976. It now offers a variety of vocational and academic courses as
well as general counseling. Participation in these programs is voluntary,
and changes in the program content will be introduced only with the approval
of both the inmates and the staff.
Social research and psychological testing are also conducted in pris-
ons. Projects include studies of the factors which may contribute to criminal
25
behavior (such as cytogenetic anomalies or socioeconomic and psychological
stress), comparison of effectiveness of various rehabilitative programs in
reducing recidivism, psychological assessment of criminals as compared with
noncriminal counterparts, tracking the outcome of judgments concerning "dan-
gerousness," and evaluating standards for determining competency to stand
trial.
Examples of biomedical research on practices intended to improve the
health or well-being of subjects in prisons are studies to reduce the spread
of infections in crowded environments or to develop new methods of treating
drug addiction. Other research, which may or may not be intended to bene-
fit subjects, includes investigations to increase understanding of the nature
and causes of narcotic or alcohol abuse and addiction.
Research conducted or supported by PHEW . Information was made available
to the Commission by the Public Health Service (PHS) regarding all biomedical
research projects involving prisoners that were conducted or supported since
January 1, 1970. In addition, the National Institute of Mental Health (NIMH)
provided information on all behavioral research with prisoners that was con-
ducted or supported since July 1, 1971. A summary of this information follows.
Biomedical research with prisoners was conducted or supported by five of
the six PHS agencies, the exception being the Health Resources Administration.
The Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA) reported
conducting over 40 intramural research projects in its testing facility at
the Addiction Research Center in Lexington, Kentucky. These studies involved
a wide range of activities, such as developing methods for detecting drugs of
26
abuse through urinalysis, studies of various properties of morphine and other
narcotics, evaluations of methadone, studies of the effects of amphetamines,
analysis of interactions of various drugs with narcotics, and assessment of
the addictive or abuse potential and psychoactive effects of new drugs. ADAMHA
also supported nine extramural studies involving prisoners, including studies
of the XYY chromosome anomaly, assessment of clinical methods to predict epi-
sodic violence, study of the use of narcotic antagonists to treat addict in-
mates in a prison and in a work release program, and study of behavioral and
biological correlates of alcoholism.
The Center for Disease Control reported three studies with prisoners;
these involved vaccines and skin test studies for a parasitic disease. FDA
conducted five studies with prisoners, all of which involved oral administra-
tion of a standard dose of a commercially available antibiotic (Penicillin or
Tetracycline). FDA also supported three studies with prisoners (two evaluating
skin sensitization by irritants and one studying cyclamates). In the Health
Services Administration, research involving prisoners was conducted by physi-
cians at one PHS hospital (13 studies of metabolic responses to prolonged bed
rest) and by physicians and behavioral scientists at the Research Division,
Bureau of Prisons (33 studies involving a wide range of activities, such as
dental care, weight reduction and tattoo removal; many were behavioral and
rehabilitative rather than biomedical in focus). Seven institutes of the
National Institutes of Health reported support of a total of 19 research pro-
grams involving prisoners. This research included studies of vaccines (rubella,
rubeola, cholera toxoid, influenza and other respiratory viruses, streptococcus"
testicular cell function, treatment of sun-induced skin conditions, responses
27
to infectious diseases (colds, cholera), pathogenesis of acne, and the effect
of diet on blood pressure and lipids.
Behavioral research with prisoners conducted or supported by NIMH in-
cluded psychological and social research studies of crime and delinquency,
individual violence, institutionalization, and law-mental health interactions.
Participation of prisoners as subjects in these studies was essential due to
the nature of the inquiries. A small number of intramural studies conducted
at St. Elizabeths Hospital were related to analysis of procedures used to
determine competency to stand trial or assess dangerousness of criminally
insane patients. Support was provided for 19 extramural studies, some of
which had biomedical as well as behavioral components. This research included
studies (1) to identify sources and patterns of criminal and delinquent be-
havior (the XYY syndrome, attitudes toward criminal behavior); (2) to develop,
test or evaluate models for the prevention, treatment or remediation of crimi-
nal behaviors (prediction of violence, lithium treatment for aggressive behavior,
impact of imprisonment on the families of black prisoners, perceptions of the
minority prison community, effects of prison environment stress on physical
and mental health of inmates and staff); and (3) to define and analyze critical
issues in law and mental health interactions (due process in determination of
criminal insanity, assessment of adequacy of treatment for offenders committed
to mental institutions, release of dangerous mental patients, the impact of a
"dangerousness" standard as the sole criterion for involuntary commitment).
In addition, NIMH has been directed by Congress to study the factors contri-
buting to homosexual rape in prisons.
28
Chapter 4. Extent of Research Involving Prisoners
The Commission obtained information from all fifty states and the
Federal Bureau of Prisons on the policies of each toward research involving
prisoners and whether or not research, if permitted, is being conducted.
Also, the Pharmaceutical Manufacturers Association surveyed its members to
assess the extent of pharmaceutical research involving prisoners. These
surveys do not document what is generally considered to be a significant
amount of social and behavioral research conducted by scholars and by the
prison system itself.
Research in state and federal prisons . To ascertain the status of
state laws, regulations and policies governing research involving prisoners,
and to determine where such research is being conducted, state correctional
agencies and the Federal Bureau of Prisons were surveyed during the summer
of 1975. The following information is based on the reports received at the
time from the state-wide agencies and the Bureau of Prisons. It should be
noted that the policies and research activities of county and municipal
jails were not surveyed.
1. Of the 21 states that permit biomedical research and the 23
states that permit behavioral research in prisons, studies are being con-
ducted in the state prisons of only seven and five states, respectively.
2. Of the seven states in which biomedical research is conducted,
all of the programs are unrelated to the health or well-being of the subjects
and primarily involve drug and cosmetic testing.
29
3. Of the five states in which behavioral research is conducted, all
of the programs are characterized 9s therapeutic in four states, and both thera-
peutic and nontherapeutic research (so characterized) in one state. No state
reported conducting research programs involving behavior modification.
4. Eight states prohibit biomedical research: one by legislation, six
by departmental policy, and one by moratorium; twenty-two have no specific policy.
5. Five states prohibit behavioral research: one by legislation,
three by departmental policy, and one by moratorium; twenty- three have no specific
policy.
6. Research is being conducted only in states that have specific
legislation or departmental policies permitting and regulating it.
7. Information provided by the Federal Bureau of Prisons indicated
that both biomedical and behavioral research are permitted by departmental
policy. Biomedical research (limited to addiction research at Lexington)
and behavioral research projects are being conducted.*
Participation of prisoners in pharmaceutical testing . The Pharmaceutical
Manufacturers Association conducted a survey of its members to ascertain the
extent to which they used prisoner volunteers as subjects for drug testing in
1975, with the focus primarily on phase 1 studies. Fifty-one companies, repre-
senting three-fourths of the members' annual expenditures for research and
development, responded to the survey. Sixteen of the 51 used prisoners as sub-
jects.
* In March 1976, the Director of the Federal Bureau of Prisons announced that
all biomedical research in federal prisons would be discontinued.
30
Of these 16 companies, 14 conducted phase 1 drug research with pris-
oners, employing a total of nearly 3600 prisoners in 100 protocols studying
71 substances. For nine companies, phase 1 testing represented their only
use of prisoners as subjects. The percentage of phase 1 testing subjects
who were prisoners ranged from 100% (one company) to 2%, with a median of
50% (an average could not be calculated from the data given). The companies
listed a total of eight state and six county or municipal prisons as research
sites. Ten companies used only minimum security prisons. No companies used
detainees in their research. Other categories of volunteer subjects which
the companies reported using in phase 1 studies included college students,
medical students, company employees, residents of foreign countries, mili-
tary personnel, members of fraternal organizations, medical personnel, and
the general population.
Thirty-three of the 51 companies indicated that they had insurance
policies or other mechanisms for compensating subjects who might be injured
in research. (There was no determination of the extent to which such poli-
cies or other mechanisms would provide compensation in the absence of legal
liability.)
31
PART III. ACTIVITIES OF THE COMMISSION
Chapter 5. Site Visits to Prisons
The Commission made a site visit to the State Prison of Southern Michigan
at Jackson on November 14, 1975. In addition, groups of Commission members
visited Washington State Penitentiary in Walla Walla, the Michigan Intensive
Program Center at Marquette, and the California Medical Facility at Vacaville.
Prior to the visits. Commission members were briefed by a former prison admin-
istrator, a former prisoner, and a director of research from a pharmaceutical
manufacturing firm, regarding conditions to look for and questions that might
be asked.
The State Prison of Southern Michigan at Jackson is the largest peniten-
tiary in the United States, housing over 5000 residents. It is also the site
of one of the largest nontherapeutic biomedical research operations, with
special buildings on the grounds constructed by two pharmaceutical manufacturers
(Parke-Davis and Upjohn) specifically to conduct phase 1 drug studies.
Commission members toured the prison facilities, including regular and
honor cellblocks, prison industries, the prison infirmary, and the research
buildings. They discussed prison procedures with the deputy warden, and
research procedures with the vice-chairman of the committee that reviews each
research protocol and with members of the research teams. Most of their visit
was devoted to discussion of prison conditions and the research program with
prisoners.
33
According to materials made available to the Commission, the research
conducted at Jackson is primarily phase 1 drug testing, although some phase
2 studies and device testing are also performed. Research protocols must be
reviewed and approved by the Protocol Review and Protection Committee (com-
posed of five physicians in the community and at Michigan medical schools,
two lawyers and a third lay member) and by the Director of the Department of
Corrections. Annual reports of research performed are made to the Review and
Protection Committee and the Department; any adverse reactions that occur are
reported to the Committee immediately.
Information about the research program is included in the packet of infor-
mation an inmate receives upon entering the prison; there is no additional re-
cruitment or contact with the prisoners by the research personnel unless he
requests information about participation. Then the program is described to him
in a group meeting, and if he wishes to be considered for research he undergoes
a physical examination and laboratory screening tests. Eligibility is contin-
gent upon approval of the prison authorities and passing the screening tests;
in addition, subjects must have an IQ of at least 70.
Those who qualify enter a common subject pool maintained for the two com-
panies on a card file. When a new protocol is initiated, prisoners' cards are
pulled from the front of the file, and the specific protocol is described to
them. If they decline to enter the study, they reenter the pool. The studies
are about equally divided between inpatient and outpatient trials. Pay is
based on the procedures involved, according to a schedule devised by the Pro-
tection Committee and approved by the Department of Corrections, and is compara-
ble to pay received in prison industries. Of the 5200 prisoners at Jackson,
34
approximately 800 are in the research subject pool. The Commission was ad-
vised that medical supervision is close, that a physician is present or on
call in the irmiediate vicinity at all times, that a prisoner can discontinue
participation in a project at any time,* and that no notation of his partici-
pation in research is made in his official prison record, so that the parole
board is not advised of it.
Commission members talked with a representative sample of 80 prisoners
both individually and in groups. The sample was selected by Commission staff
from the master list of all prison residents, and included both research parti-
cipants and nonparticipants who responded to an invitation to meet with the
Commission. In addition, prisoners suggested by other inmates were interviewed
in a group setting. Overall impressions from this experience were that pris-
oner-participants valued the research opportunity. In general, they felt that
they were free to volunteer for or withdraw from the program at will and were
given adequate information about research protocols. Nonparticipants expressed
various reasons why research was not for them, but did not object to its being
available for others.
Participants gave many reasons for volunteering for research, including
better living conditions, need for a good medical evaluation, and desire to
perform a worthwhile service to others, but it was clear that the overriding
motivation was the money they received for participating. In fact, their
strongest objection was that the pay for participation in research was held
* A consent form provided as a sample for review contained a contrary implica-
tion. The drug company representatives readily acknowledged that this was a
istake, however, and they gave assurances that the form would be corrected.
mi:
35
down to levels comparable to prison industries. Other complaints focused on
limitations to participation rather than on research excesses: if a prisoner
stayed on an inpatient study for more than a week, he would lose his prison
job seniority; prison officials were said to exclude certain prisoners arbi-
trarily; some prisoners did not seem to get called to participate in research
as often as others. They generally rejected the notion that they were -coerced
into participating in research, and stated that they knew their participation
would not be revealed to the parole board.
The major complaints of the participants were directed toward the prison
system, not the research program. When asked if research in prisons should be
stopped, the prisoners interviewed unanimously said no. They urged correction
of what they viewed as inequities ( e.g. , that pay be increased, that authorities
be forbidden arbitrarily to withhold permission to participate), but asked that
biomedical research programs in prisons be allowed to continue.
As a follow-up to the visit to Jackson, the Commission staff compared the
characteristics of the 792 men in the drug-testing pool on November 27, 1975
with a randomly selected control sample of similar size. Data came from a
computer print-out of the prison's daily roster. Subjects were disproportionately
white; although blacks comprise almost 68% of the nonsubject prison population,
they are only about 31% of the subject pool. (Data furnished to the Commission
by Dr. William Woodward of the University of Maryland showed a similar inverted
racial pattern in the biomedical research program at the Maryland House of
Corrections at Jessup.) At Jackson, subjects tended to be older than nonsubjects,
to have been in prison much longer (an average of almost two years, compared to
one year for nonsubjects), and to have been sentenced to Jackson more times (2.1
36
times compared to 1.8 times for nonsubjects). There was also a striking over-
representation among the subjects of men housed in the prison's two honor
blocks.
In order to observe behavioral programs operating in a prison setting,
groups of Commission members visited a unit of the Washington State Peniten-
tiary at Walla Walla and the Michigan Intensive Program Center at Marquette.
Neither program is conducted as research, and the Commission is not aware of a
behavior modification program in a state or federal prison that is so conducted
at present.
The program at Walla Walla utilized a therapeutic community approach, and
dealt with the state's most difficult-to-manage prisoners, who were sent to
the unit generally because of unacceptable conduct in the regular system. The
unit is operated almost entirely by the prisoners themselves, who serve as the
therapeutic community, establishing and enforcing rules of conduct. On entering
the program, a prisoner is placed in an isolation cell. His only contacts are
visits by the director and other prisoners on the unit, who explain the rules to
him and urge him to conduct himself in such a way as to be able to join them.
When he is willing to conform, he is released from his cell to the open ward.
There, the main emphasis becomes retraining in appropriate patterns of social
interaction, using such mechanisms as group discussions of current events, rec-
reational programs, and group therapy. Swearing, use of jargon, and fighting
are among the numerous forbidden behaviors; violations are punished by a return
to the isolation cell, with the group serving as enforcer of the rules and deter-
mining when the violator can return to the ward.
37
The primary purpose of the Walla Walla program is to encourage learning
of socially acceptable behavior rather than specifically to prepare the pris-
oners for return to the outside world or the regular prison system. Most men
remain on the unit for long terms. Those who have been released outside the
prison are said to have done remarkably well, with recidivism a rare event
(follow-up records are apparently not maintained). Return to the regular prison
system would be dangerous, since those in the program gain reputations as informers.
Interviews with prisoners in the program yielded only the highest praise for it.
Prisoners admitted initial resentment of the isolation treatment, but claimed
that it was the only way they had ever been made to think seriously about them-
selves and their behavior, and that it provided the necessary impetus for their
behavior change.
The Michigan Intensive Program Center (MIPC) at Marquette is a maximum
security facility housing difficult-to-manage prisoners who have been trans-
ferred from other facilities in the state. The behavioral program there is based
on a six-level token economy. Privileges and comforts increase as a resident earns
enough tokens to progress from the lower to the higher levels. Tokens are earned
for correct behavior (making the bed, cleaning the cell, attending educational
activities, not fighting, etc.) and are awarded at frequent intervals throughout
the day. The purpose of the program is to improve the prisoner's behavior suffi-
ciently to enable him to return to the regular prison system and be manageable
there.
Interviews with prisoners at the MIPC indicated no enthusiasm for the program.
The prisoners seemed to tolerate it grudgingly and submit to the process in order
to get back into regular prison life, but with the determination that nothing done
38
to them in the program was really going to change their behavior. They gener-
ally viewed the program as "just another lock-up," no better or worse than the
segregation blocks to which they might have been assigned alternatively. Their
major objection was the arbitrariness by which the prison system could decide
to send them to the MIPC. No figures were available on recidivism, nor was there
any other means to document the effectiveness of the program.
Commission members also visited the California Medical Facility at Vacaville .
which houses approximately 1400 inmates. Most of the prisoners are referred to
Vacaville for medical or psychiatric reasons, and one-fourth of the population
is excluded from participation in research for security reasons. Those who wish
to volunteer sign a roster at the research office, and selection of subjects is
made in numerical order from this list.
Research conducted at Vacaville includes a large program of skin-testing
for hypersensitivity, as well as internal administration of experimental drugs.
New volunteers begin with a skin-test study before advancing to higher paying
pharmaceutical studies.
Other paying prison jobs are available, and at the time of the visit there
were unfilled slots for reasons that were unclear but possibly had to do with
disparity in pay or difficulty of the work as compared with participation in
research. Legal counseling is available from law students who visit the prison
weekly. Educational programs range from elementary school through a bacca-
laureate degree. There is spot censorship of mail. Telephones are available,
but the inmates must pay to use them.
39
The inmates' council reviews all research projects and can veto any
protocol. Most of the active protocols have also been reviewed by Institu-
tional Review Boards of outside institutions. Informed consent is obtained
in writing, and the prisoner receives a copy of the signed form. Examination
of a card file indicated a significant dropout rate from studies; apparently
prisoners feel free to withdraw, even though they know that if they do so
frequently, their chances of being invited to participate in future studies
will be reduced.
40
Chapter 6. National Minority Conference on Human Experimentation
In order to assure that minority viewpoints would be heard, the Commission
contracted with the National Urban Coalition to organize a conference on human
experimentation. The conference was held on January 6-8, 1976, at the Sheraton
Conference Center, Reston, Virginia. Attended by over 200 representatives, it
provided a format for presentations of papers and workshop discussions from
which a set of recommendations emerged. The papers and the recommendations rele-
vant to prison research are summarized below.
Joyce Mitchell Cook, Ph.D . Dr. Cook suggests that ethically acceptable
research may be assured by a principle of equality ( i.e. , that researchers not
propose experiments which they or members of their family would not participate
in). She argues that the term "informed consent" is ambiguous, since it v^rongly
places the emphasis upon process and information rather than on voluntariness.
Dr. Cook adopts the position that volunteering is genuine only if the end to be
pursued is one to which the volunteer is devoted. Because of the extraneous
motives of prisoners, she concludes that they are volunteers in name only. She
recommends that behavioral research be permitted only if it directly benefits
the participants and can be conducted on hospital wards rather than in prisons.
Dr. Cook concludes that experimentation on prisoners ought to be abolished and
that the risks of experimentation should be distributed more equally among mem-
bers of the free-living world. <
Larry I. Palmer, J.D . Mr. Palmer begins with the premise that the ethical
problems posed by prison experimentation derive from racial, religious and
41
nationalist conflicts and that the issues of prisoners and race are merged.
He recommends guidelines to encourage scrutiny of: (1) the appropriateness
of using prisoners in a particular protocol, (2) the societal priorities asso-
ciated with the research, and (3) the potential risks and procedures to mini-
mize such risks. He suggests that research involving prisoners might be regu-
lated by state officials, with additional monitoring and scientific evaluation
by professionals and some supervision of the consent process. All decisions
and consequences regarding experimentation in prisons should be open to public
scrutiny. Mr. Palmer sees little justification for a ban on all research in
prisons; rather, he advocates a "scrutiny of values," through a statement of
the nature, purposes and risks of each protocol in relation to the interests
of the prison population.
L. Alex Swan, Ph.D., LL.B . Dr. Swan argues that behavioral research is
aimed at quelling dissident prisoners who view their incarceration in political
and economic terms. He suggests that such research ought instead to promote
"human liberation" by exposing oppressive conditions in prison. He advocates
self-determination for prisoners, particularly with regard to the goals of
social and behavioral research, and challenges social and behavioral scientists
to accept responsibility for the possible misuse of their research findings.
Dr. Swan asserts that scientific manipulation of prisoners to conform to the
will of the state is unethical, just as it is unethical to use scientific tech-
niques for disciplinary or punitive purposes. He further states that experi-
mentation on the brain to alter behavior violates the inmate's independence and
right to free speech, that the prison system is so inherently coercive that in-
formed and voluntary consent is impossible, that labeling of prisoners as aggres-
42
sive or violent for research purposef is dishonest and repressive, and that
civil liberties are endangered by behavior modification techniques in prisons
because of the closed nature of such institutions.
Recommendations of Minority Conference workshops on research involving
prisoners . Two workshops were devoted to the topic of research involving
prisoners. The first of these recommended a moratorium on all nontherapeutic
biomedical research in prisons until a comprehensive evaluation of human experi-
mentation has been made. This evaluation should include consideration of the
purpose of research involving prisoners, criteria for selection of subjects,
assessment of risks, government responsibility for regulating research in pris-
ons, responsibility of professional organizations regarding such research, the
role of prisoners in the supervision of the research, the fixing of financial
responsibility including compensation for harm resulting from research, and
access of prisoners to official bodies outside the prison. The workshop also
recommended that behavioral research be redirected from a focus on the indivi-
dual prisoner to the goal of understanding the nature of prisons and their
effects on individual prisoners. Recommendations were not proposed regarding
informed consent because of doubts that it is possible to obtain informed con-
sent in our prisons.
The second workshop recommended the establishment of a permanent commission
to regulate human experimentation, a ban on biomedical research and psychosurgery
in prisons, establishment of a human subjects review committee with prisoner
representation, and the provision of technical and legal resources to prisoners
who are potential subjects of human experimentation.
43
Chapter 7. Public Hearing
On January 9, 1976, the Commission conducted a public hearing on the issue
of research involving prisoners. Summaries of the presentations that were made
to the Commission follow.
Gabe Kaimowitz (Senior Staff Attorney, Michigan Legal Services) suggested
that researchers assume that there is informed consent, and that they often
fail to use adequate control subjects, particularly in behavioral research.
Further, investigators may limit public access to information about prison
research projects. He stated that they often use captive populations without
considering the availability of community volunteers, and too often apply medi-
cal or psychological models inappropriate to economic and social problems.
Prisoners are in an inherently coercive environment, and their consent to re-
search is always suspect. Mr. Kaimowitz is not opposed to therapeutic biomedi-
cal or behavioral research when the prisoners themselves request its implementa-
tion. In such situations a review committee should examine the conditions that
caused the prisoners to make such a request.
Matthew L. Myers (National Prison Project of the American Civil Liberties
Union Foundation) stated that informed consent is not feasible in the prison
environment. Regardless of prison policy concerning participation in research
and parole, prisoners may believe that involvement contributes to early release.
They may also participate to escape from the routine of prison life or to earn
money for necessities. Mr. Myers said that most medical experimentation is
conducted in medium or maximum security facilities in which conditions are
44
oppressive, alternatives are few, and there is a potential for abuse due to
the closed, isolated and coercive nature of the prisons.
William R. Martin, M.D . (Director, Addiction Research Center, National
Institute on Drug Abuse, DHEW) stated that addiction research is important
and necessary both for society and for the prisoners. Limiting such research
will retard development of therapy for addicts and will prohibit the evaluation
of the addictive properties of new analgesics. Research participation is bene-
ficial to most prisoners, he said, in that it is generally a safe and construc-
tive experience, often improves health, and is a source of pride. Dr. Martin
has been unable to identify any other population in which such studies can be
done as validly and safely as in prisoners. He feels that prisoner partici-
pation may be altruistic, and therefore society should compensate participants
for their involvement and for any injuries that may occur. There is empirical
evidence that prisoners can and do make informed judgments, and are equally
knowledgeable about research programs as other subjects. Practical measures
can be taken to minimize the seductiveness of the research setting compared
to the prison environment.
Theodore Francis (Occupational Drug Use Program, New York State Office
of Drug Abuse Services) urged that biomedical and behavioral research in
prisons continue, but that more attention be paid to compensation, the level
of health care provided to subjects, and review of behavioral research.
Participation of prisoners should be judged an acceptable means of earning
money, and inmates should be reimbursed according to discomforts and risks
incurred. Money earned should be held in escrow for prisoners until release
45
or paid to their families. A national board should review all behavior modi-
fication research for efficacy, validity, and risks to individuals and to the
community. This board would issue public notices in lay language, describing
dates and place of the research, as well as the reimbursement provisions.
Michael S. Lottman (Commission on the Mentally Disabled, American Bar
Association, and the National Association for Retarded Citizens) urged that
special care be given to protecting the rights of mentally disabled prisoners.
Thereafter, testifying as an individual , he opposed nontherapeutic biomedical
research on prisoners which exposes them to risk of discomfort, pain or inca-
pacity. He stated that the coercive and oppressive nature of penal institutions
precludes obtaining voluntary informed consent. Prisoners are not physiologi-
cally unique and therefore provide no information which cannot be gained from
a free population. Research on prisoners benefits drug companies and researchers-
he said. If research is to continue in prisons, particular care should be given
to protecting the rights of mentally retarded prisoners, and an independent
body should certify that each subject can and has given informed consent.
Mr. Lottman is not opposed to therapeutic biomedical research in a prison
setting, provided there are proper controls and consent procedures.
Joseph Stetler (President, Pharmaceutical Manufacturers Association) stated
that to the best of his knowledge no prisoner has died or been permanently in-
jured from research sponsored by drug companies. He advocated continuation of
drug research in prisons provided that: (1) researchers are qualified, (2) faci-
lities are adequate, (3) participation is voluntary and informed, (4) research
is monitored, and (5) prisoners are compensated fairly. He stated that prisons
46
are practical and safe for drug testing, and that discontinuance of such re-
search might delay development of new drugs. He estimated that 85% of all.
phase 1 drug testing is done on prisoners, and that the rate of compensation
could increase substantially and still be insignificant relative to the total
cost of new drug development. Prisoner testing of cosmetics or over-the-
counter drugs is minimal relative to research involving prescription medica-
tions. A 1975 policy statement of PMA on the conduct of clinical research was
summarized,
Allan H. Lawson (Executive Director, Prisoners' Rights Council of Pennsyl-
vania) held that prisoners should be permitted to participate in experimentation
only if the decision is absolutely voluntary. This is impossible in today's
prisons, he said, because of economic pressures, forced idleness and inhuman
conditions. In his view, research programs provide an excuse to prison admin-
istrators to neglect responsibilities such as housing, medical care and job
programs. Because of the reality of economic pressures, the Prisoners' Rights
Council would permit some research in prisons provided safeguards are instituted,
until other means of earning money are available. However, the Council would
ban research which involves exposure to incurable diseases or is otherwise
dangerous or unnecessary. Mr. Lawson urged that medical care and compensation
be provided for inmates injured during research.
The Reverend Americus Roy (Prisoners Aid Association of Maryland, Inc.)
testified against medical experimentation in prisons based on personal experience
at the Maryland House of Corrections. Prisoners participate in research, he said,
because of economic deprivation and as a temporary escape from inhuman conditions.
47
Use of prisoners is exploitative of the economicany depressed. Risks of
research should be widely distributed, especially among those who are likely
to benefit.
48
PART IV. REPORTS TO THE COMMISSION
Chapter 8. Philosophical Perspectives
Papers on the ethical issues involved in research with prisoners were
prepared for the Commission by Roy Branson, Ph.D., Cornel Ronald West, M.A.,
and Marx W. Wartofsky, Ph.D.
Dr. Branson first analyzes the ethical principles underlying the standard
arguments for and against research involving prisoners, and, secondly, examines
several policy alternatives. He concludes by recommending a moratorium, appeal-
ing to the principles of free and informed consent and justice.
In reviewing arguments for experimentation. Dr. Branson cites three
justifications generally advanced in support of research involving prisoners:
(1) that it contributes to the good of society, of which prisoners are members
and therefore recipients of benefits; (2) that it is an appropriate way for
prisoners to make reparation; and (3) that prisoners can, in fact, give free
and informed consent. A varient of the third argument is that criminal con-
viction presupposes competence and responsibility; therefore, prisoners must
be presumed to have the capacity to volunteer. In fact, advocates of this
position point out that prisoners are permitted to choose work in hazardous
industries and so should be permitted to choose work as research subjects as
well .
Opponents of prison research assume that experimentation is different
from other occupations. A person's relationship to his body is not his re-
lationship to his goods. A person's body, in a special and real sense, is
49
the person. In experimentation risk to bodily integrity is primary to the
activity, whereas in other occupations, the risk is secondary.
The two fundamental principles to which opponents of experimentation
appeal are free and informed consent and justice. Those citing consent can
say that prisoners cannot in principle give free consent because of the in-
herent nature of prisons as coercive, total institutions. Other opponents
appealing to free consent do not go so far. They claim that sufficiently
free consent to experimentation cannot in fact be given in American prisons.
They cite not only the coercive structure of prisons, but such administrative
features as limited alternative to earn money in prisons (none for equivalent
rates of pay), and indeterminate release dates with nonobjective or unknown
conditions for leaving the prison. Dr. Branson identifies himself with the
second position, saying that empirical analyses leave a serious and reasonable
doubt that inmates of American prisons can in fact give a sufficiently free
consent to experimentation.
Justice is the other principle to which opponents of prisoner experi-
mentation appeal. Injustice can take the form of injury, when a person is
wrongfully harmed through exploitation or negligence by others. Injustice
can also result from failure to follow the basic requirement of distributive
or comparative justice: that like cases are to be treated alike and different
cases be treated differently. Since prisoners are in relevant respects equal
to free persons, the burdens of risk and harm should be proportional to those
of free-living citizens, which would entail a significant reduction in at
least phase 1 drug trials. On the other hand, prisoners are unequal to free
persons in important respects in that they have been placed in total institutions.
50
Dr. Branson, citing comparative justice, says the similarities of prisoners
to free persons requires that the proportion of experimentation utilizing
prisoners should be reduced. The differences between experimentation con-
ducted on prisoners and those conducted on free persons require that pris-
oner experimentation be stopped, at least until conditions change.
In applying principles to policy alternatives. Dr. Branson sees remunera-
tion as a major and finally insurmountable practical obstacle to prisoner ex-
perimentation. The principle of informed consent dictates that in order for
prisoners to give consent that is not coerced, they should not be paid more
for experimentation than for other prison jobs. But the principle of justice
requires that rates of remuneration to prisoners should be equivalent to the
rates paid to free volunteers. Schemes relying on committees of prisoners
(or prisoners and prison officials) controlling funds created by the difference
between the standard amount paid by drug companies and what an individual pris-
oner received run into practical problems, for the committee itself could mani-
pulate and coerce prisoners.
Dr. Branson's recommendation, therefore, is that the Commission declare
a moratorium on prison research and suggest that if and when conditions in
American prisons have improved, then research might be resumed in those faci-
lities which can meet the requirements of informed consent and justice. He
would not preclude the possibility of offering innovative therapy to an indi-
vidual inmate in need of treatment, but this, he says, should be distinguished
from programs of "therapeutic research" which blur the distinction between
individual therapy and experimentation. He suggests, in addition, that the
moratorium extend to behavioral research, since new behavioral therapies may
51
be evaluated first on nonprisoners, but that observational research (nonin-
terventional behavioral research), as well as educational programs, be per-
mitted to continue.
Mr. West advocates a contractual approach to human experimentation which
requires full disclosure, written consent and choices that are rational. These
requirements reflect the human rights to know, to choose and to be treated fairl)/
He distinguishes between coercion (which involves threats) and bribery (which
involves manipulation of incentives). Mr. West considers requests for prisoners
to participate in research to be bribery, not coercion; hence, choice is at
play. The paucity of alternatives and the conditions of domination within pris-
ons, however, undermine the rational basis for such choice. Mr. West concedes
that a certain degree of control over prisoners might be warranted, but only
to the extent that basic human rights are not violated. The necessity for such
control, he believes, suggests that prisoners are less appropriate subjects for
research than are nonprisoners. Therefore, he urges that normal volunteers be
recruited, instead; but he cautions against shifting the burden of research to
Third World populations.
Mr. West views behavioral research in prisons to be nontherapeutic, inasmuch
as the rehabilitative efficacy of behavior modification programs has not been
demonstrated. Thus, he would restrict such research according to the same
principles he applied for nontherapeutic biomedical research.
Mr. West recommends termination of both nontherapeutic biomedical and
"therapeutic" behavioral research involving prisoners until such time as prison
reform creates the conditions necessary for their legitimate participation in
such research.
52
Dr. Wartofsky begins his essay on selling the services of one's body
for research by discussing the extent to which being a subject is similar to
other forms of wage-labor. He examines the nature of that which is being
sold (and bought), and the extent to which a person has the right to offer
his or her body in exchange for money. His position is that whereas one may
not sell one's body, as such, nevertheless one may sell the disposition over
the use of one's body for specified purposes, for a specified time and under
specified conditions. In other words, while one's life and liberty are
inalienable rights (which cannot be separated from one's person and sold),
one's services or capacities are commodities which, in our free-market social
and economic system, are regularly exchanged for wages.
Dr. Wartofsky then considers the problem of risk-taking. In general,
he says, no ethical question arises concerning the risks inherent in dan-
gerous occupations, since the workers are seen as having free choice in
undertaking or refusing such jobs, and the risks involved are secondary to
the needs of society which the occupations ( e.g. , coal mining, construction
work, chemical manufacturing) are designed to meet. By contrast, the nature
of risk in research is such that one is placing one's health or well-being
at risk not as a by-product of some other purpose, but as the primary commodity;
and it is the intimacy of the relation between one's person and one's well-
being which makes the exchange disturbing.
With respect to motivation. Dr. Wartofsky observes, it is generally
assumed that placing oneself at risk for monetary gain is for one's own bene-
fit, whereas doing it without tangible reward is more altruistic. However,
he points out that one may place oneself at risk for monetary gain and, at
the same time, be self-sacrificing (if, for example, the purpose is to support
53
one's family or otherwise satisfy the needs of others). Whether working for
the abstract "good of society" is a higher motive than working for one's
family is a question which cannot be settled. Thus, he concludes, motivation
should be considered (if at all) only to the extent that the seriousness of
the motivation should be commensurate with the degree of risk to be undertaken.
Next, he considers the extent to which prostitution is like wage-labor,
involving, as it were, the sale of a disposition over one's body for a certain
purpose, at a certain rate and for a certain time. The relevance of the inquiry
lies in the fact that what is being bought and sold in prostitution is (just as
in participation in research) something which is "so intimate to one's per-
son that there is something disturbing in the notion that it is alienable,
as a commodity." In his view, the ethical objections to prostitution, and to
being a paid research subject, derive from the translation of relations which
are supposed to express fundamental aspects of humanity into an economic ex-
change. In the paid research context, both the investigator and the subject
are reducing an essential human capacity (putting oneself at risk for others)
to a commodity; so doing, they may dehumanize each other.
Here, he observes, society is faced with a dilemma: on the one hand,
research with human subjects is important for the preservation and well-being
of the species; on the other hand, the only means of conducting such research
is ethically questionable. He sees three obvious solutions: (1) to stop
paying the subjects; (2) to conduct only that research which can be carried
out with unpaid volunteers; and (3) to restructure society in order to elimi-
nate the economic need which induces (or coerces) the disadvantaged into making
up the largest portion of paid research subjects. All of these "solutions,"
54
however, are impractical. The pragmatic solution which he recommends, there-
fore, is to minimize the exploitive elements which "commodify" the situation.
An alternative would be to follow the model proposed by Hans Jonas in which
the most valuable members of society (rather than the most expendable) under-
take the risks, but Dr. Wartofsky considers this also to be impractical.
Finally, he proposes that both paid and unpaid research subjects be organized,
educated as to their rights, and represented at all levels of review (Institu-
tional Review Boards as well as state and federal commissions). This, he be-
lieves, would socialize the interaction, reduce the alienation, and ameliorate
the dehumanizing effects of the commodity relationship for both the paid sub-
jects and the researchers.
55
Chapter 9. Sociological and Behavioral Perspectives
In order to obtain an understanding of the nature of the social structure
of a prison and its implications for the prisoner's freedom and competence to
make a choice for or against involvement in research, the Commission requested
papers by two sociologists: Jackwell Susman, Ph.D., and John Irwin, Ph.D. In
addition, Martin Groder, M.D., prepared a paper on behavioral research aimed
at rehabilitation of prisoners. These essays are summarized below.
Dr. Susman suggests that a determination regarding prisoners' partici-
pation in biomedical or behavioral research depends on understanding their
value system and how it deviates from conventional norms. He describes two
sets of norms in prison society: (1) the norms which the staff and officials
endorse and which support their authority, and (2) the norms of the inmates,
which encourage diversity of behavior and subversion of the official system.
It is generally agreed that custody involves profound attacks on the
prisoner's self-image through deprivation and control. Inmates cope with the
"pains of imprisonment" through various social structures, norms and values.
From the sociological literature on prisons and prison life. Dr. Susman identi-
fies two descriptive models of prison society: the "prisoner solidarity"
image and the "prisoner diversity" image.
As described by Dr. Susman, the prisoner solidarity image classifies pris-
oners according to their conformity to or deviation from the inmate code which
encourages cohesion and mutual support among prisoners vis-a-vis their captors.
Adherence to the inmate code helps protect the average inmate and strengthens
56
his dignity. A negative aspect of this social structure is the dependence
of most prisoners on the few leaders for privileges and protection. The con-
vict leaders are granted special privileges by the administration in return
for maintaining order, and thus seem to have little incentive to participate
in biomedical and behavioral research. The rest of the inmates may adapt
differently to prison life. Some may conform with varying degrees of inten-
sity to the demands of the inmate code, and might reject biomedical and be-
havioral research since the code rejects conventional values and cooperation.
Others may deviate from the norms of the prisoners' world and participate in
research to obtain the goods and services their outcast status denies them.
Still others may combine conformity and deviance to maximize their chances
of leaving prison emotionally and physically unscathed; their participation
in research would depend on a careful analysis of the costs and benefits, in
terms of their life in prison and their chances of getting out. Finally,
some may conform completely to the official norms and may volunteer for re-
search for both altruistic and pragmatic reasons.
The second model of prison society, the prisoner diversity image, focuses
on the inmates' identification with persons or groups outside the prison. In
this view, the inmates bring subcultural norms and values with them into prison,
and, thus, prison society is diverse. This model describes inmates according
to three categories. First is the career criminal or professional thief, who
assumes a commitment not to prison life but to criminal lifestyles. His objective
is to do his time and get out, not to manipulate the prison environment. He may
volunteer for research believing that it will be considered favorably by the
parole board, or merely to maximize his comfort until he is released. Second
57
is the "convict," who is oriented primarily to prison life and seeks status
by manipulating the environment, winning special privileges and asserting
influence over others. His participation in research is improbable because
it might imply cooperation with the staff. The third group of inmates identify
with "legitimate" subculture outside the prison. They have no commitment to
the values of thieves or convicts and seek status through the means provided
by the prison administration. They are usually rejected by the convict and
thief subcultures, and might be expected to volunteer for research projects.
Dr. Susman examines the implications of these models of prison society
for the requirements of informed consent: competency, knowledge and volun-
tariness. Rejecting the Kaimowitz court's view of the effects of institution-
alization. Dr. Susman believes that prisoners are able to maintain an identity.
He suggests that prisoners' autonomy may expand or contract depending on their
circumstances, and that at least some prisoners have sufficient autonomy to give
informed consent to participate in research. Providing prisoners with knowledge
of the risks associated with research may be difficult, but Dr. Susman believes
in principle that it can be done satisfactorily. With respect to voluntariness,
both images of prison society indicate that prisoners have a great deal of power
and influence over how the prison is run. This implies that mechanisms could
be developed to insulate research activities from staff and peer pressure.
Dr. Susman concludes that prisoners can have the freedom and competence to give
informed consent.
Dr. Irwin agrees with Dr. Susman that biomedical research involving pris-
oners should not be categorically denied, but rather permitted under conditions
58
that protect against the disparity of bargaining power between prisoners and
authorities. Instead of a contract model (which assumes relatively equal
bargaining power) Dr. Irwin suggests a "rights model," in which minimal rights
are established and guaranteed against abuse of power. He observes that con-
ditions of degradation and coercion vary with the degree of autonomy and iso-
lation under which prisons operate, and he believes that most of the constraints
(including arbitrary use of discretionary powers) are, in fact, unnecessary and
could be abandoned without interfering with effective operation of the penal
system. This, he says, would make the prison environment compatible with con-
ditions necessary for the ethical conduct of research.
Dr. Irwin recommends, therefore, an accreditation process and an ongoing
review mechanism, in which prisoners, their families and civil rights groups
all participate, with a concomitant reduction of discretionary powers now
held by prison authorities. He would also require that drug firms pay at the
same rate that they pay nonprisoner participants, but that the difference
between those wages and the prevailing prison wages be placed in a fund to
increase the wages for the general prison population. He would also elimi-
nate any leakage of information to parole boards about research participation.
Finally, he recommends that there be established a review and grievance mecha-
nism independent of the prison system in which prisoners, their families and
civil rights organizations would participate. This mechanism would review all
decision-making relative to prisoners' rights and perhaps consider, as well,
such factors as the adequacy of the health care available to the prisoners.
Dr. Groder , formerly warden-designate of the Federal Correctional Insti-
tution at Butner, North Carolina, observes that of all research involving
59
prisoners, only therapeutic psychosocial research directly addresses "the
promise of rehabilitation." Unless society is willing deliberately and in-
tentionally to abandon its commitment to rehabilitation, he argues, research
of high quality is essential if services are to be provided to offenders in
a safe, effective and humane manner. He believes that offenders, as wards of
the state, have a "right to treatment" that will be abridged if correctional
research is abolished or stifled through overregulation.
Dr. Groder accepts the likelihood that the Commission will wish to recommend
additional regulatory procedures, and suggests the following goals: (1) "wards
of the state" should be provided an opportunity to rejpin the social mainstream;
(2) the quality of consent should be audited to protect basic rights of volun-
teers; (3) provision should be made for care, compensation, and possible rever-
sal if a bad effect occurs; and (4) the outcome of all research should be pub-
lished. Dr. Groder recommends that Congress appoint regional boards with the
responsibility of achieving the four goals and ensuring prisoner rights. The
boards would approve or disapprove projects, and appeals could be made to the
federal court of appeals. The boards should sponsor studies of the correctional
process and the impact of research, and make recommendations to Congress regarding
pertinent legislation.
Dr. Groder believes, on the basis of his experience, that therapies can be
devised to enable prisoners to reenter and remain in the mainstream of society,
and he cautions that a ban or limitation on such research will ensure that no
correctional innovations will be developed. Therapeutic techniques that become
available in nonprison society may also be denied to prisoners, and that would
pervert the desire to rehabilitate prisoners as well as infringe upon their
right to treatment.
60
Chapter 10. Legal Perspectives
The Center for Law and Health Sciences, Boston University School of Law,
prepared for the Commission an analysis of the law relevant to determining the
validity of consent by prisoners to their participation in research. This
analysis proceeded on the assumption (consistent with the findings of the Com-
mission) that quality of information and ability to comprehend do not generally
constitute problem areas in prison research. The key issues reviewed by the
Center are whether consent can be given voluntarily in the prison environment,
and whether voluntary consent to treatment (and, by extension, to behavioral
programs that might not constitute "treatment") is required. The first of
these issues is discussed primarily in the context of nontherapeutic biomedical
research, and the second is raised in connection with behavior modification pro-
grams.
Motivations of prisoners to participate in nontherapeutic research include
financial reward, hope for reduction of sentence, seeking of medical or psychia-
tric help, relief from tedium, desire for better or more secure living conditions,
attraction of risk-taking, altruism, etc. The conditions that give rise to these
motivations may constitute duress such as would render a contract voidable and,
by analogy, render it difficult if not impossible to uphold a prisoner's "informed
consent" to participation in research. It has been argued, but not determined
as a matter of law, that incarceration inherently constitutes such coercion (or
duress) that nontherapeutic research should not be conducted in prisons. In the
absence of such a determination, courts will examine particular prison situation'
for evidence of duress in obtaining consent to participation in research.
61
Thus, as to financial reward, the questions to be asked are whether there
are alternative sources of equal income and, more importantly, whether partici-
pation in research is the only way prisoners can earn enough money to maintain
a minimum standard of living. As to living conditions, the questions would
concern the extent of deprivation in the prison, and the contrast between the
prison environment and conditions in the research center. These are matters
of fact that would be examined in a particular situation to determine whether
a consent was voluntary.
Promise of reduction of sentence is now generally thought to be inherently
coercive, but, at least with respect to rehabilitative treatment that may be
of experimental nature, sentence reductions have been tied to prisoners' con-
sent. Cases involving waiver of rights indicate that even in a coercive situa-
tion, rights may be waived if adequate safeguards, e.g. , counsel, are provided.
Medical treatment generally constitutes a battery if the patient has not
consented to it. Although one jurisdiction has not applied this rule in cases
involving prisoners, other jurisdictions have held to the effect that imprison-
ment does not deprive a person of the capacity to decide whether or not to con-
sent to health care. The latter rule has been applied in cases dealing with
physically invasive behavior modification techniques, but there is no holding
on the right to withhold consent to noninvasive behavior modification techniques.
Whether or not the techniques were experimental does not appear to have been
material in any of the holdings. Rather, the courts appear to have taken into
account the degree of invasiveness.
State regulations and statutes dealing with experimentation on prisoners
cover the entire spectrum, from permission to total bans of such research.
62
Where any sort of research involving prisoners is permitted, a requirement
that informed consent be obtained is explicitly set forth. Where financial
or other rewards are explicitly covered, they are generally limited or pro-
hibited. The recently published DHEW proposals related to research on pris-
oners follow the states that permit such research by accepting the view that
prisoners can consent to be subjects so long as adequate safeguards are pro-
vided. The proposals published for public comment by DHEW (November 16,
1973) include such safeguards as a required certification by a review commit-
tee that there are no undue inducements to participation by prisoners, taking
into account the comparability of the earnings otherwise offered; a require-
ment that no reduction in sentence or parole in return for participation in
research be offered unless it is comparable to what is offered in return for
other activities; and a provision for accreditation by DHEW of prisons in
which research is to be supported or conducted. A subsequent DHEW Notice of
Proposed Rulemaking (August 23, 1974) adds a requirement that the review com-
mittee also take into account whether living conditions, medical care, etc.
would be better for participants than those generally available to prisoners,
but deletes the provision for accreditation by DHEW.
The report by the Center for Law and Health Sciences concludes with the
following recommendations: that provision for accreditation by DHEW should
be made, to ensure that research will not be conducted under such circumstances
that participation is the only way for a prisoner to obtain minimally decent
living conditions; that the rewards for participation should not be such that
they provide the only way for a prisoner to maintain his health and personal
hygiene, or induce a person to incur great personal risks; that parole or a
63
reduction in sentence should never be offered in return for participation
in research; that there should be some provision for the protective role
of an independent counselor; that full information about the research should
be given the prospective participant, and that he should not be asked to
waive his rights against anyone for injuries that he might sustain. If
these safeguards are adopted, the law generally will recognize the informed
consent of a prisoner to participation in research.
64
Chapter 11. Alternatives and Foreign Prac t ices
Alternatives employed in the United States and foreign countries to the
conduct of biomedical research in prisons were examined by the Commission.
A paper on alternative populations for conducting phase 1 drug studies was
prepared by Dr. John Arnold. Information on two programs using normal volun-
teers as alternatives to prisoners, one for vaccine testing and one for
general physiologic testing, was provided by staff reports. An additional
staff report was prepared on the use of prisoners in a research program
located in a hospital outside of the prison. Practices in foreign countries
related to development and testing of new pharmacologic agents were surveyed
and reported to the Commission by Mr. C. Stewart Snoddy and Dr. Marvin E.
Jaffe, Clinical Research International, Merck Sharp & Dohme.
The Quincy Research Center, Dr. John Arnold, Director , is an innovative
phase 1 drug testing program using cloistered, normal volunteers. It was
recently established in Kansas City, Missouri. Dr. Arnold, an investigator
with 29 years of experience in drug testing in prisons, highlights some of
the practical and ethical problems associated with the use of such a research
population, and explains the reasons he now believes that the use of prison
inmates as research subjects should be phased out. He identifies limitations
imposed by the prison system on the optimal conduct of such studies, and his
reasons for believing that the use of nonprisoner volunteers for them is pre-
ferable. Cloistering, he says, is necessary to enable the researcher to strictl.
control the medications received, to intensively monitor subjects for signs of
adverse effects, and to identify drug properties with greater confidence. In
65
contrast with research facilities designed exclusively for the cloistering
of free-world volunteers for phase 1 studies, however, prisons are neither
built nor operated around the needs of medical research. The prison environ-
ment may be poorly controlled, particularly with regard to the presence of
contraband drugs that may seriously influence the result of a clinical trial.
Further, the dropout rate for his free-world studies has been about 1.5 per-
cent, a lower rate than he experienced in a prison setting.
Dr. Arnold suggests that the behavioral problems associated with cloistering
volunteers are the greatest barrier to the development of alternative populations^
and require sensitivity with regard to volunteer selection, adequate preparation
for the experience of complete control of life-style, and physical facilities
that are attractive and interesting. The second largest problem is the cost.
While lodging and food contribute to this expense, the single largest increment
stems from the greater degree of supervision and closer medical control required
for volunteers in a nonprison setting.
Despite the problems. Dr. Arnold believes the advantages make the use of
nonprisoners preferable. One advantage he cites relates to compensation for
injury, which the consent form should address. While an indemnification plan
similar to those governing other occupational hazards can be arranged for non-
prisoner volunteers, it cannot necessarily be done for prisoners. Rates for
the Quincy workman's compensation insurance are based on data that show the
risks for participants in phase 1 drug research to be only slightly greater
than the occupational risks for office secretaries, one-seventh of those for
window washers, and one-ninth of the risks for miners. The problem of rendering
66
long-term follow-up and extended care, because prisoners are not likely to
return to prison for follow-up examinations or medical attention, is also
reduced by using a free-living population.
Dr. Arnold believes that three advantages of the free-world volunteer
system will eventually lead to its exclusive use: (1) paid stipends can be
comparable to wages paid for other services, (2) indemnification can be offered
under plans similar to workman's compensation, and (3) volunteers may choose
medical research against other forms of limited employment without any special
coercive force.
Dr. Arnold described characteristics of the population attracted to his
nonprisoner volunteer program, based on the last 150 subjects at the Quincy
Research Center. The men were 80% white, 15% black, and 5% other racial back-
ground. Age group was 50% age 20-30, 40% age 30-40, and 10% age 40-55. Ninety
percent were recently or seasonally unemployed, 8% steadily unemployed, and 2%
were college students. Most had completed 8th grade, 60% had completed 12th
grade, 2% were college students, and 0.5% were college graduates. Approximately
60% of the subjects were former prisoners; 5 to 10% had been subjects in
Dr. Arnold's earlier studies in prisons.
The Clinical Research Center for Vaccine Development (CRCVD) was developed
to provide an alternative to the use of prisoners in infectious disease research.
It was established in 1974 under a contract with the National Institute of
Allergy and Infectious Diseases (NIAID), the primary inpetus being NIAID's
desire to develop a dependable source of healthy, adult volunteers that would
circumvent many of the problems plaguing its prison-based research and allow
67
infectious disease research to continue. A contract was awarded to the Uni-
versity of Maryland School of Medicine to demonstrate the feasibility of
recruiting adult volunteers from the community for research in which live
attenuated vaccines for respiratory viruses and mycoplasma are administered
to subjects to test infectious capability, symptoms produced, ability to in-
duce immunity, and contagiosity.
The CRCVD is under the direct supervision of two physician-researchers
who conduct the protocols developed by NIAID. They are assisted by two part-
time recruiters, a consulting psychologist, and support staff. The facility
is part of the University of Maryland School of Medicine complex in Baltimore;
its major unit is a self-contained, limited access, air-sealed isolation ward,
where volunteers reside for the duration of the study.
Recruiting procedures have focused on attracting young, intelligent
and healthy adults, to minimize problems with informed consent and adjustment
to the dormitory-like setting of the isolation ward. College students were
selected as the free-world population most likely to meet these requirements.
Recruiters present information on the program at college campuses; interested
students subsequently meet with the recruiters so that a blood sample may be
drawn. Those volunteers who pass this initial screening procedure are contacted
by the recruiters and offered the opportunity to participate as subjects.
Most of the studies conducted by the CRCVD last between 15 and 30 days.
During a two-day acclimation period on the unit, there are intensive educa-
tional presentations concerning vaccine development and the upcoming study,
preliminary medical and psychological screening procedures are conducted, and
68
the volunteers become acquainted with the isolation ward environment and
staff. The researchers reserve the right to dismiss volunteers prior to
inoculation, but thereafter only the subject may choose to withdraw from
a study. To supplement the consent form, an examination is administered
prior to inoculation, to assess and document the participant's comprehension
of the research protocol. Each volunteer must pass this exam before being
permitted to participate in a study.
The volunteers earn $20 per day on the isolation ward, based on what
the average college student might earn in a summer job. Volunteers who
withdraw from the study are paid up to the point they drop out, whether or
not a public health quarantine has been imposed, requiring every subject to
remain on the ward until completion of the study. The consent forms note
that any medical problems that may arise will be treated at the CRCVD's ex-
pense.
As of June 1975, 70 volunteers had participated in nine studies, and the
subject pool consisted of 547 people. The age range is between 18 and 50.
Of the 70 people who have completed studies, there were 4 with less than four
years of high school, 30 high school graduates, 19 college undergraduates,
12 college graduates, and 5 with advanced degrees; 84% were white, 7% were
former prisoners.
The Normal Volunteer Patient Program of the Clinical Center, National
Institutes of Health , was established in 1954 and represents one of the
earliest efforts to involve members of the community in experimental studies.
Volunteers participate in research designed primarily to measure the parameters
69
of normal body functions. Most of the subjects are members of certain religious
sects which view participation in this program as part of their public service
commitment ( e.g. , Church of the Brethren, Mennonites, Mormons) and college stu-
dents. While the volunteers in both categories receive little in terms of fi-
nancial compensation (usually restricted to transportation and living expenses),
the student volunteers, who reside at the Clinical Center for up to three months
on "career development internships," are offered an opportunity to study with
NIH scientists in many of the research laboratories. Hence, the program appeals
primarily to students interested in careers in the health sciences and related
fields.
Recruitment of many of the volunteers for the program is done by colleges
under contract with the NIH. The contractor college or university is responsi-
ble for handling all the local recruitment details, transporting the volunteers
to and from the Clinical Center, and providing any transportation required for
follow-up procedures. In return, the contractor receives a fixed fee for each
volunteer (to cover the cost of round trip air fare and ground transportation
to and from the airport) plus a certain amount for each day of the volunteers'
time and inconvenience.
Prospective participants in the program are advised of its purposes and
the restrictions in life-style they may experience during their sojourn at
the Clinical Center. Studies in which they are asked to participate include,
for example, studies of normal physiology (awake, asleep and during exercise),
psychological studies (reaction time, attention), dietary manipulation, studies
involving drugs, hormones or tracer doses or radioisotope administered either
70
orally or by injection, and exposure to viruses or biochemical products
derived from viruses or bacteria.
The Eli Lilly Company Research Unit located at Wishard Memorial Hospital,
Indianapolis, Indiana, employs prisoner and nonprisoner normal volunteers in
phase 1 drug studies. The prisoners come to the hospital unit from Pendleton
State Reformatory 30 miles away; most of them have previously participated in
pharmaceutical studies in the Lilly unit at the prison. All studies involving
the initial administration of an agent to humans, use of radioisotopes, or tests
requiring complex monitoring equipment are done at the hospital unit rather than
at the prison unit.
Prisoner volunteers, in order to qualify for participation in the Lilly
hospital research program, generally must meet the basic work-release require-
ments: a date set for parole or for a parole hearing, and one year of good
behavior. In addition, specific permission from the warden is required. These
restrictions are imposed to make escape less likely. Other work-release choices,
when available, generally offer better pay and more freedom of movement. A
prisoner participates at the hospital only once and returns to the prison after-
ward. The stay at the hospital may be as long as three months. While at the
hospital, prisoners are required to remain on the research ward. They have
limited recreation facilities but may have visitors daily. No special security
precautions are taken, but escapes from the unit have been rare.
Two hospital wings adjoining the prisoner research unit are used for
phase 2 studies in patients and phase 1 studies in nonprisoner normal volun-
teers. The later are generally men off the streets, chronically unemployed.
71
who know of the program and request on their own, often repeatedly, to parti-
cipate in drug studies. Prisoners and nonprisoners usually are not involved
in the same protocol, although the types of studies are the same. Nonprisoners
are paid $7 a day; the prisoners receive $3 a day (the rate established as the
maximum by the prison).
Advantages of the hospital as the setting for research of this type are
the availability of excellent emergency care (although no serious adverse
reactions requiring it have occurred in 10 years of operation), the ease of
access of the investigator to the subjects, and surroundings that are pleasant
in comparison with the prison. Disadvantages are the limited number of pris-
oners who can qualify for the program and the boredom of the research. The
main reason men drop out of a study is that they become bored and ask to
return to their friends and activities at the prison.
Human studies in pharmaceutical research and development in other
countries . The survey* conducted on practices of foreign countries regarding
use of prisoners and other groups in the development and testing of new pharma-
ceutical agents included seven European nations, five English speaking countries,
four Latin American nations and Japan. In all the countries surveyed, clinical
pharmacology studies (pharmacokinetic and dose-ranging studies) can be conducted
in normal subjects. Almost uniformly, these countries do not permit such studies
to be conducted in prisoners. In theory, prisoner studies could be done in the
United Kingdom, but in practice no such research is conducted in prisoners out-
* Provided to the Commission by Marvin E. Jaffe, M.D. and C. Stewart Snoddy,
Merck Sharp & Dohme Research Laboratories.
72
side the United States. In most countries volunteers, when used, are students,
civil servants (military, police and firemen), and medical and paramedical per-
sonnel .
In general, clinical pharmacology studies conducted abroad involve patients
with the disease which the drug is intended to treat, rather than normals. The
use of patients with other diseases is not uniformly approved, but may be per-
mitted if data relevant to the primary indication can be obtained. The require-
ment for specific governmental approval (IND or clinical trials certificate) to
conduct clinical pharmacology studies in normal subjects or patients also varies
among countries. In all the countries surveyed, human pharmacokinetic and
pharmacodynamic data are "helpful" to support new drug registration. In about
half the countries, such data are mandatory. Only France and Japan require that
such data be generated in the indigenous population; other countries accept
foreign data.
With the exception of Italy, no country requires long-term (1-3 months)
controlled safety studies in volunteers before initiating studies in patients.
For registration purposes, however, Belgium, Italy, Canada, and in some cases
the United Kingdom require such data. Since prisoners are not used in those
countries for such studies, it is assumed that such data often are generated
elsewhere. In most countries, longer term studies to determine the safety of
a new drug entity are done in the patient population which the drug is intended
to treat. This provides a measure of how the drug may be expected to behave
in clinical practice under the more usual conditions of use and when combined
with the usual concomitant therapies. The subjects of such studies receive
the presumed benefits of therapy with the new agent to balance its unknown risks.
73
Although prisoners have not been subjects in phase 1 drug testing in
other countries, they have been subjects of nontherapeutic research. For
example, prisoners in a number of countries, including Australia, Canada,
Denmark, England, Germany, Greece, Ireland, Mexico, Poland and Japan, have
been surveyed to determine the incidence of the XYY chromosome anomaly.
74
Chapter 12. Survey of Review Procedures, Investigators and Prisoners
Data on research in prisons were presented by the Survey Research Center,
University of Michigan, in a preliminary report to the Commission on a study
of institutional review procedures, research on human subjects, and informed
consent. Data were presented from interviews done in early 1976 with investi-
gators in 41 studies and representatives of review committees in five prisons,
with 181 prisoner-subjects in four of these prisons, and with 45 prisoner-non-
subjects in two of these prisons. The subjects had all participated in research
since July 1, 1974. No individuals or institutions were identified in the report.
The research . As described by principal investigators in the five prisons,
their research was predominantly pharmaceutical research, mostly phase 1 testing.
In most of the studies, drugs were administered orally and blood and urine sam-
ples were analyzed. Very few of the experiments, according to investigators,
were intended to benefit subjects, although researchers felt that a medical or
psychological benefit might occur in some cases. The research also entailed
some medical and psychological risk according to investigators, although they
estimated the probability of serious risk to be \jery low or nonexistent. All
investigators reported the existence of procedures for treating subjects who
might suffer harmful effects of the research.
Review procedures . The Survey Research Center found that the structure of
the review process differed among the five prisons. In some places it included
Institutional Review Boards (IRB's) established in compliance with DHEW regula-
tions on protection of human subjects; in others it included review committees
75
appointed by the state department of corrections, by prison authorities, or
by university officials. The review process at some prisons included commit-
tees created by drug companies. Biomedical and legal consultants and pris-
oner representatives played a role in some review procedures. At all prisons,
the review was conducted in stages involving different combinations of the
above mechanisms. Membership on review committees was reported as being very
stable.
While few proposals are rejected in the review process, it was reported
that few are approved as submitted. Most frequent changes are in consent
procedures, though modifications were also reported in research design. The
process was said to work smoothly, at least in part because of long-standing
relations between review committees and investigators, and awareness of mutual
expectations. Little monitoring of the actual conduct of research was reported,
although most members of review committees were said to have visited the prison
or research facilities at some time.
The prisoner subjects . The interviews with prisoner subjects revealed
them to be generally supportive of biomedical research in prisons. The near
concensus of favorable attitude among subjects occurred in all four institutions
where prisoners were interviewed. Practically all of these subjects said that
the information they received in advance of the experiment was understandable
and correct, that the researchers were willing to answer subjects' questions,
and that participation was voluntary. About one-third of the subjects indicated
that they expected the research would involve some risk. A few subjects none-
theless felt that they had experienced specific difficulties as a result of the
76
experiments that they did not fully expect. Subjects offered a number of
reasons for participating in research, the most prevalent being financial.
About 90% of them said that they would be willing to participate in future
experiments.
Consent forms . The Survey Research Center's analysis of consent forms
provided by investigators indicated that almost all described the purpose of
the experiment, and all described the procedures. About 85% mentioned and
listed risks. An analysis of the reading ease of consent forms indicated
that a large proportion were at a difficult reading level. The difficulty
did not appear to be solely attributable to the use of medical and technical
terminology; some of the difficulty was related to the complexity of sentence
structure and the nature of many of the nontechnical terms that were employed.
Reading difficulty appeared to be greater for consent forms associated with
projects that investigators estimated to entail relatively higher risks. The
explanations provided in the consent forms, however, were supplemented in all
cases by oral explanations.
Nonsubject prisoners . Prisoners who have never participated in research
projects, or whose participation was not recent, were less favorable, on the
average, toward research in prisons than were the current subjects. Differences
of opinion about research were more apparent within the group of nonsubjects
than within the group of subjects. Some nonsubjects were strongly opposed to
research in prisons. Prisoners offered a number of explanations for not parti-
cipating, including assertions that they had not been asked, that they feared
the possibility of serious harmful effects, that they mistrusted research or
77
researchers, or that they were opposed to the idea of research in general.
Some said that they would participate if they were asked and/or if the bene-
fits to themselves were more substantial. Nonsubjects who were interviewed
had a slightly lower level of formal education than did the subjects, and
the former were less likely to have prison jobs. Furthermore, for those in-
mates who held jobs, the number of hours worked per week was slightly lower
for nonsubjects than for subjects.
Suggestions from respondents . Relatively few prisoners offered suggestions
about how studies on human beings might be improved. Increased payment, better
facilities ( e.g. , rooms to be used exclusively for research purposes), more com-
plete explanation of possible harmful effects ( e.g. , pamphlets or written
materials explaining projects), and better treatment ( e.g. , taking more time
with subjects and exercising more care) were among the suggestions of prisoners.
Some nonsubject prisoners suggested abolishing the research program.
Principal investigators also offered few suggestions. Some proposed that
rules and review procedures be simplified and made less rigid. Others suggested
that larger review committees be established, that committee members should have
experience in dealing with prisoner volunteers, and that the committee procedure
be made less susceptible to the biases of individual members.
78
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